{ "FullStudy":{ "Rank":218137, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512251", "OrgStudyIdInfo":{ "OrgStudyId":"11952" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"CBKM120ZUS21T", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Novartis" } ] }, "Organization":{ "OrgFullName":"University of California, San Francisco", "OrgClass":"OTHER" }, "BriefTitle":"BKM120 Combined With Vemurafenib (PLX4032) in BRAFV600E/K Mutant Advanced Melanoma", "OfficialTitle":"A Phase 1/2 Trial of BKM120 Combined With Vemurafenib (PLX4032) in BRAFV600E/K Mutant Advanced Melanoma (Novartis Study Number CBKM120ZUS21T)" }, "StatusModule":{ "StatusVerifiedDate":"April 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 9, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 13, 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"March 21, 2017", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 20, 2011", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"February 23, 2018", "ResultsFirstSubmitQCDate":"April 16, 2018", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"May 16, 2018", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"April 16, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 16, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Alain Algazi", "ResponsiblePartyInvestigatorTitle":"Assistant Clinical Professor - Melanoma Oncology", "ResponsiblePartyInvestigatorAffiliation":"University of California, San Francisco" }, "LeadSponsor":{ "LeadSponsorName":"University of California, San Francisco", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Novartis", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"This is a phase 1/2 clinical trial with the goal of determining whether the addition of the investigational agent BKM120 to vemurafenib will lead to improved 6-month progression-free survival in patients with BRAFV600E/K mutant melanoma.", "DetailedDescription":"The phase 1 portion of this trial is a dose escalation study; the phase 2 portion is a single-stage, single arm prospective clinical trial. All patients will receive continuous doses of vemurafenib twice a day and BKM120 once a day.\n\nIn the phase 1 portion of the study, there will be a 7 day lead-in period to allow for single dose pharmacokinetic analysis of BKM120 alone. Cycle 1 (28 days) is the dose-limiting toxicity (DLT) period. During phase 1, vemurafenib and BKM120 doses will be escalated using a standard 3+3 dose escalation scheme with the goal of identifying the recommended phase 2 dose.\n\nIn the phase 2 portion of the study, patients will receive continuous doses of vemurafenib and BKM120 starting on day 1 of the first cycle. In the phase 2 portion of the study, patients will receive vemurafenib and BKM120 at the recommended phase 2 dose." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "BRAF Mutant Metastatic Melanoma" ] }, "KeywordList":{ "Keyword":[ "BKM120", "BRAF", "Melanoma", "PI3K" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1", "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"8", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"No Previous Treatment", "ArmGroupType":"Other", "ArmGroupDescription":"150 mg oral dabrafenib twice a day until disease progression, death, or unacceptable adverse events.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: BKM120 Combined with Vemurafenib (PLX4032)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"BKM120 Combined with Vemurafenib (PLX4032)", "InterventionDescription":"Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)\n\nDose Level -1: BKM120 60 mg daily, Vemurafenib 480 mg bid\n\nDose Level 1: BKM120 60 mg daily, Vemurafenib 720 mg bid\n\nDose Level 2: BKM120 80 mg daiy, Vemurafenib 720 mg bid\n\nDose Level 3: BKM120 100 mg daiy, Vemurafenib 720 mg bid\n\nDose Level 4: BKM120 100 mg daiy, Vemurafenib 960 mg bid\n\nPhase II is a single-stage, single arm prospective trial: patients will receive BKM120 and vemurafenib at the RP2D", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "No Previous Treatment" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Phase 1 - Safety & Recommended Phase 2 Dose (RP2D)", "PrimaryOutcomeDescription":"RP2D determined by MTD, post-DLT period toxicity, and pharmacokinetic data", "PrimaryOutcomeTimeFrame":"28 days" },{ "PrimaryOutcomeMeasure":"Phase 2 - Progression-free Survival Rate", "PrimaryOutcomeDescription":"6 month progression-free survival rate (PFS6) determined by tumor assessments, clinical tests and laboratory tests", "PrimaryOutcomeTimeFrame":"6 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Secondary Outcome 1 Phase 2 - Objective Response Rate", "SecondaryOutcomeDescription":"Objective response rate determined by tumor assessments, clinical tests and laboratory tests.\n\nData not collected: study was terminated early due to dose limiting toxicities.", "SecondaryOutcomeTimeFrame":"Day 28 (+/- 3) of even-numbered treatment cycles until progression" },{ "SecondaryOutcomeMeasure":"Secondary Outcome 2 Phase 2 - Safety and Tolerability", "SecondaryOutcomeDescription":"Determined by clinical and laboratory tests, and AE assessments", "SecondaryOutcomeTimeFrame":"During study treatment, up to 2 years" },{ "SecondaryOutcomeMeasure":"Secondary Outcome 3 Phase 2 - PTEN Expression", "SecondaryOutcomeDescription":"PTEN expression associated with better PFS determined by laboratory tests.", "SecondaryOutcomeTimeFrame":"No time limit" },{ "SecondaryOutcomeMeasure":"Secondary Outcome 4 Phase 2 - PI3K-pathway Signaling Reduction Levels", "SecondaryOutcomeDescription":"Greater reduction in PI3K-pathway signaling associated with better PFS determined by laboratory tests and tumor assessments.", "SecondaryOutcomeTimeFrame":"No time limit" },{ "SecondaryOutcomeMeasure":"Secondary Outcome 5 Phase 2 - PI3K Pathway Gene Expression Levels", "SecondaryOutcomeDescription":"Responding tumors lack gene expression signatures of PI3K pathway activation, and progressing tumors demonstrate gene expression signatures of PI3K pathway activation - determined by laboratory tests and tumor assessments.", "SecondaryOutcomeTimeFrame":"No time limit" },{ "SecondaryOutcomeMeasure":"Secondary Outcome 6 Phase 2 - MAPK Pathway Gene Expression Levels", "SecondaryOutcomeDescription":"Responding tumors lack gene expression signatures of MAPK pathway activation, and progressing tumors demonstrate gene expression signatures of MAPK pathway activation - determined by laboratory tests and tumor assessments.", "SecondaryOutcomeTimeFrame":"No time limit" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria\n\nHistologically or cytologically confirmed diagnosis of unresectable stage III and stage IV melanoma\nBRAFV600E or BRAFV600K mutation-positive\nAge ≥ 18 years\nECOG performance status ≤ 2\nPatients must have at least one site of measurable disease (per RECIST for solid tumors)\nLife expectancy of ≥ 12 weeks\nAdequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hb >9 g/dL\nTotal calcium (corrected for serum albumin) within normal limits (biphosphonate use for malignant hypercalcemia control is not allowed)\nMagnesium ≥ the lower limit of normal\nPotassium within normal limits for the institution\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal range (or ≤ 3.0 x upper limit of normal (ULN) if liver metastases are present)\nSerum bilirubin within normal range (or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)\nSerum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min\nSerum amylase ≤ ULN\nSerum lipase ≤ ULN\nINR ≤ 2\nFasting plasma glucose ≤ 120 mg/dL (6.7 mmol/L)\nNegative serum pregnancy test within 48 hours before starting study treatment\n\nExclusion Criteria\n\nPatients who have received prior treatment with a PI3K inhibitor or a BRAF inhibitor, prior treatment with sorafenib is permitted.\nPatients with a known hypersensitivity to BKM120 or to its excipients\nPatients with untreated brain metastases are excluded; however, patients with metastatic CNS tumors may participate in this trial, if the patient is > 4 weeks from therapy completion (incl. radiation and/or surgery) and clinically stable at the time of study entry\nPatients with acute or chronic liver, renal disease or pancreatitis\n\nPatients with the following mood disorders as judged by the Investigator or a psychiatrist, or as a result of patient's mood assessment questionnaire:\n\nMedically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, history of suicidal attempt or ideation, or homicidal ideation\n≥ CTCAE grade 3 anxiety\nMeets the cut-off score of ≥ 10 in the PHQ-9 or a cut-off of ≥ 15 in the GAD-7 mood scale, respectively, or selects a positive response of \"1, 2, or 3\" to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) will be excluded from the study unless overruled by the psychiatric assessment\nPatients with diarrhea ≥ CTCAE grade 2\n\nPatient has active cardiac disease including any of the following:\n\nLeft ventricular ejection fraction (LVEF) < 50% as determined by MUGA or ECHO\nQTc > 480 msec on screening ECG (using the QTcF formula)\nPersonal or family history of prolonged QT syndrome\nAngina pectoris that requires the use of anti-anginal medication\nVentricular arrhythmias except for benign premature ventricular contractions\nSupraventricular and nodal arrythmias requiring a pacemaker or not controlled with medication\nConduction abnormality requiring a pacemaker\nSymptomatic pericarditis\n\nPatient has a history of cardiac dysfunction including any of the following:\n\nMyocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function\nHistory of documented congestive heart failure (New York Heart Association functional classification III-IV)\nDocumented cardiomyopathy\nPoorly controlled diabetes mellitus (HbA1c > 8 %)\n\nOther concurrent severe and/or uncontrolled concomitant medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol\n\n- Significant symptomatic deterioration of lung function; if clinically indicated, pulmonary function tests including measures of predicted lung volumes, DLco, O2 saturation at rest on room air should be considered to exclude pneumonitis or pulmonary infiltrates\n\nImpairment of GI function or GI disease that may significantly alter the absorption of BKM120 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\nPatients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug; erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued\nPatients who are currently receiving treatment with medication with a known risk to prolong the QT interval or inducing Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug\nPatients receiving chronic treatment with steroids or another immunosuppressive agent; topical applications, inhaled sprays, eye drops or local injections are allowed; patients with previously treated brain metastases, who are on stable low dose corticosteroids treatment for at least 14 days before start of study treatment are eligible\nPatients who have taken herbal medications and certain fruits within 7 days prior to starting study drug - herbal medications include, but are not limited to St. John's Wort, Kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, and ginseng; fruits include CYP3A inhibitors: Seville oranges, grapefruit, pomelos, or exotic citrus fruits\nPatients who are currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug; note that co-treatment with weak inhibitors of CYP3A is allowed).\nPatients who have received chemotherapy or targeted anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug must have resolution of treatment related adverse events to baseline or grade 1 before starting the trial\nPatients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy\nPatients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy\nPatients who are currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant\n\nWomen who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control; women of child-bearing potential must have a negative serum pregnancy test ≤ 72 hours prior to initiating treatment; double barrier contraceptives must be used through the trial by both sexes; oral, implantable, or injectable contraceptives are therefore not considered effective for this study\n\nWomen are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [for US only: and estradiol < 20 pg/mL] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.\nWomen of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during treatment for 3 months in total after study drug discontinuation. Highly effective contraception is defined as either: True abstinence-when this is in line with the preferred and usual lifestyle of the subject, periodic abstinence and withdrawal are not acceptable methods of contraception; Sterilization-have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; Male partner sterilization-for female subjects, the vasectomised male partner should be the sole partner for that patient; Use of a combination of any two of the following barrier methods of contraception-condom or Occlusive cap with spermicidal foam/gel/film/cream/vaginal suppository\nFertile males, defined as all males physiologically capable of conceiving offspring must use condom during treatment, for 3 months in total after study drug discontinuation and should not father a child in this period\nKnown diagnosis of human immunodeficiency virus (HIV) infection\nHistory of another malignancy within 3 years, except cured or curable basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; patients with lesions curable by excision must have these lesions excised prior to the initiation of treatment on study\nPatient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"University of California, San Francisco", "LocationCity":"San Francisco", "LocationState":"California", "LocationZip":"94115", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"30801911", "ReferenceType":"derived", "ReferenceCitation":"Algazi AP, Rotow J, Posch C, Ortiz-Urda S, Pelayo A, Munster PN, Daud A. A dual pathway inhibition strategy using BKM120 combined with vemurafenib is poorly tolerated in BRAF V600(E/K) mutant advanced melanoma. Pigment Cell Melanoma Res. 2019 Jul;32(4):603-606. doi: 10.1111/pcmr.12777. Epub 2019 Apr 13." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Vemurafenib-Naïve", "FlowGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Vemurafenib-Resistant", "FlowGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Dose Level -1", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"5" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"5" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Phase I, Dose 1", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"5" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"5" } ] } } ] } },{ "FlowPeriodTitle":"Phase I, Dose 2", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Phase I, Dose 3", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Phase I, Dose 4", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Phase II", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Vemurafenib-Naïve" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Vemurafenib-Resistant" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"3" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"5" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"8" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"44", "BaselineMeasurementLowerLimit":"26", "BaselineMeasurementUpperLimit":"75" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"51", "BaselineMeasurementLowerLimit":"40", "BaselineMeasurementUpperLimit":"62" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"50", "BaselineMeasurementLowerLimit":"26", "BaselineMeasurementUpperLimit":"75" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"6" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Phase 1 - Safety & Recommended Phase 2 Dose (RP2D)", "OutcomeMeasureDescription":"RP2D determined by MTD, post-DLT period toxicity, and pharmacokinetic data", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"mg", "OutcomeMeasureTimeFrame":"28 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Determination of MTD", "OutcomeGroupDescription":"Vemurafenib-Naïve and Vemurafenib-Resistant populations received:\n\n150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"8" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"60" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Phase 2 - Progression-free Survival Rate", "OutcomeMeasureDescription":"6 month progression-free survival rate (PFS6) determined by tumor assessments, clinical tests and laboratory tests", "OutcomeMeasurePopulationDescription":"Data were not collected, study never advanced to Phase II.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"6 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Vemurafenib-Naïve", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Vemurafenib-Resistant", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Secondary Outcome 1 Phase 2 - Objective Response Rate", "OutcomeMeasureDescription":"Objective response rate determined by tumor assessments, clinical tests and laboratory tests.\n\nData not collected: study was terminated early due to dose limiting toxicities.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"Day 28 (+/- 3) of even-numbered treatment cycles until progression", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Vemurafenib-Naïve", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Vemurafenib-Resistant", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Secondary Outcome 2 Phase 2 - Safety and Tolerability", "OutcomeMeasureDescription":"Determined by clinical and laboratory tests, and AE assessments", "OutcomeMeasurePopulationDescription":"Data not collected: study was terminated early due to dose limiting toxicities.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"During study treatment, up to 2 years", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Vemurafenib-Naïve", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Vemurafenib-Resistant", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Secondary Outcome 3 Phase 2 - PTEN Expression", "OutcomeMeasureDescription":"PTEN expression associated with better PFS determined by laboratory tests.", "OutcomeMeasurePopulationDescription":"Data not collected: study was terminated early due to dose limiting toxicities.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"No time limit", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Vemurafenib-Naïve", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Vemurafenib-Resistant", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Secondary Outcome 4 Phase 2 - PI3K-pathway Signaling Reduction Levels", "OutcomeMeasureDescription":"Greater reduction in PI3K-pathway signaling associated with better PFS determined by laboratory tests and tumor assessments.", "OutcomeMeasurePopulationDescription":"Data not collected: study was terminated early due to dose limiting toxicities.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"No time limit", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Vemurafenib-Naïve", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Vemurafenib-Resistant", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Secondary Outcome 5 Phase 2 - PI3K Pathway Gene Expression Levels", "OutcomeMeasureDescription":"Responding tumors lack gene expression signatures of PI3K pathway activation, and progressing tumors demonstrate gene expression signatures of PI3K pathway activation - determined by laboratory tests and tumor assessments.", "OutcomeMeasurePopulationDescription":"Data not collected: study was terminated early due to dose limiting toxicities.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"No time limit", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Vemurafenib-Naïve", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Vemurafenib-Resistant", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Secondary Outcome 6 Phase 2 - MAPK Pathway Gene Expression Levels", "OutcomeMeasureDescription":"Responding tumors lack gene expression signatures of MAPK pathway activation, and progressing tumors demonstrate gene expression signatures of MAPK pathway activation - determined by laboratory tests and tumor assessments.", "OutcomeMeasurePopulationDescription":"Data not collected: study was terminated early due to dose limiting toxicities.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"No time limit", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Vemurafenib-Naïve", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Vemurafenib-Resistant", "OutcomeGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid\n\nPhase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Vemurafenib-Naïve", "EventGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"3", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"3", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"3" },{ "EventGroupId":"EG001", "EventGroupTitle":"Vemurafenib-Resistant", "EventGroupDescription":"150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nDose Level -1:\n\nBKM120 60 mg daily Vemurafenib 480 mg bid\n\nPhase I, Dose Level 1:\n\nBKM120 60 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 2:\n\nBKM120 80 mg daily Vemurafenib 720 mg bid\n\nPhase I, Dose Level 3:\n\nBKM120 100 mg daily Vemurafenib 720 mg bid Phase I, Dose Level 4 BKM120 100 mg daily Vemurafenib 960 mg bid Phase II 150 mg oral dabrafenib twice a day (bid) until disease progression, death, or unacceptable adverse events.\n\nBKM120 Combined with Vemurafenib (PLX4032): Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"5", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"5", "EventGroupOtherNumAffected":"5", "EventGroupOtherNumAtRisk":"5" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Febrile neutropenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"5" } ] } },{ "SeriousEventTerm":"Biliary Fistula", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"5" } ] } },{ "SeriousEventTerm":"Seizure", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"5" } ] } },{ "SeriousEventTerm":"Renal insufficiency", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"5" } ] } },{ "SeriousEventTerm":"Hypotension", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"5" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"elevated LDH", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"3" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" } ] } },{ "OtherEventTerm":"Anemia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"3" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"5" } ] } },{ "OtherEventTerm":"adrenal insufficiency", "OtherEventOrganSystem":"Endocrine disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"3" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" } ] } },{ "OtherEventTerm":"eye redness", "OtherEventOrganSystem":"Eye disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"3" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" } ] } },{ "OtherEventTerm":"abdominal pain", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"3" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"5" } ] } },{ "OtherEventTerm":"vomiting", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"3" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"5" } ] } },{ "OtherEventTerm":"diarrhea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"3" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" } ] } },{ "OtherEventTerm":"nausea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"3" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"5" } ] } },{ "OtherEventTerm":"Mucositis oral", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"3" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" } ] } },{ "OtherEventTerm":"Constipation", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"3" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"5" } ] } },{ "OtherEventTerm":"Oral Pain", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"3" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" } ] } },{ "OtherEventTerm":"Fever", "OtherEventOrganSystem":"General disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { 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