{
  "FullStudy":{
    "Rank":218066,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513174",
          "OrgStudyIdInfo":{
            "OrgStudyId":"GECP10-03"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2010-024178-21",
                "SecondaryIdType":"EudraCT Number"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Spanish Lung Cancer Group",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone",
          "OfficialTitle":"Multicenter, Randomized, Phase Ib/IIb Study to Evaluate the Efficacy and Tolerability of Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone, in Patients With EGFR Mutation Positive Advanced Non-small-cell Lung Cancer",
          "Acronym":"GOAL"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2016",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2016",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 11, 2011",
          "StudyFirstSubmitQCDate":"January 16, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 25, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 26, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Spanish Lung Cancer Group",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a study of gefitinib plus olaparib gefitinib in combination with olaparib (AZD2281) versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation positive advanced non-small-cell lung cancer.",
          "DetailedDescription":"This is a multicenter, randomized, Phase Ib/IIb, open label study to evaluate the efficacy and tolerability of gefitinib in combination with olaparib (AZD2281) versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation positive advanced non-small-cell lung cancer The study will be split into 2 parts: an open label Phase I dose escalation part and a randomized controlled, open label Phase II part."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Non Small Cell Lung Cancer"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "GOAL",
              "Lung",
              "Non small cell lung cancer",
              "EGFR mutations"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1",
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"186",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Gefitinib",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Gefitinib will be administered once daily, continuously, in 28-day cycles, as a fixed dose of 250 mg/day.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Gefitinib"
                  ]
                }
              },{
                "ArmGroupLabel":"Gefitinib in combination with olaparib",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Gefitinib 250 mg once a day, in combination with olaparib (at the recommended dose in the previous Phase I study) twice a day, continuously, in 28-day cycles.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Gefitinib plus olaparib"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Gefitinib",
                "InterventionDescription":"Gefitinib 250 mg once a day, continuously, in 28-day cycles, until progression",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Gefitinib"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Gefitinib plus olaparib",
                "InterventionDescription":"Gefitinib 250 mg once a day, in combination with olaparib (at the recommended dose in the previous Phase Ib study) twice a day, continuously, in 28-day cycles.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Gefitinib in combination with olaparib"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"MTD (Maximum Tolerated Dose) defined as the highest dose level at which < 2 out of 6 patients experience a DLT",
                "PrimaryOutcomeTimeFrame":"5 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Progression-free survival",
                "SecondaryOutcomeTimeFrame":"An expected average of 2 years"
              },{
                "SecondaryOutcomeMeasure":"Overall response rate",
                "SecondaryOutcomeTimeFrame":"An expected average of 2 years"
              },{
                "SecondaryOutcomeMeasure":"Overall survival",
                "SecondaryOutcomeTimeFrame":"An expected average of 2 years"
              },{
                "SecondaryOutcomeMeasure":"Peak Plasma Concentration",
                "SecondaryOutcomeTimeFrame":"Predose, half an hour, 1, 2, 4, 6 and 12 hours post-dose"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients age 18 years or more.\nHistologically confirmed diagnosis of non-small-cell lung carcinoma.\nStage IV disease, following the Seventh Edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual (27).\nTumor tissue available (according to the criterion of the specimen-processing laboratory) for EGFR mutation assessment: to be included in the study patients should present at least one EGFR mutation (exon 19 deletion or L858R with or without T790M).\nEvidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.\nECOG score ≤ 2.\nLife expectancy of ≥ 3 months.\nFor the Phase II part of the study, patients should not have received previous treatment with chemotherapy or other agents for advanced disease: chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment, as long as a minimum of 6 months has passed since the end of the adjuvant and/or neo-adjuvant chemotherapy. This criterion is not mandatory to patients to be included in the Phase I part of the study (these patients are allowed to have received a prior line of treatment for advanced disease).\n\nPatients with the following hematologic values:\n\nAbsolute Neutrophil Count (ANC) ≥1.5 x 109/L\nHemoglobin (Hb) ≥ 10 g/dl\nPlatelets ≥ 100 x 109/L\n\nPatients with the following biochemical values:\n\nBilirubin ≤ 1.5 mg/dL\nAspartate aminotransferase (AST) and Alanine transaminase (ALT) < 1.5 upper limit of normality\nCreatinine clearance ≥ 60 ml/min.\nPatients of childbearing age of either sex must use effective contraceptive methods(barrier methods plus other birth control methods) before entering the study and while participating in the study.\nPatients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood.\nPatients must be available for clinical follow-up.\n\nExclusion Criteria:\n\nPatients diagnosed of another neoplasm, with the exception of cervical carcinoma insitu, treated squamous cell carcinoma or superficial bladder tumor (Ta and TIS), or other malignant tumors that have received curative treatment within the last 5 years before inclusion in the study.\nSimultaneous participation in any other study involving an investigational medicinal product, or having participated in a study less than 28 days prior to the start of study treatment.\nPatients with HIV infection, HCV infection, coronary disease or uncontrolled arrhythmia, uncontrolled cerebrovascular disease and other clinical conditions that, in the judgment of the investigator, contraindicate the patient's participation in the study.\nPast medical history of interstitial lung disease (ILD), drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease.\nPre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline.\nUncontrolled seizures.\nPatients considered requiring radiotherapy to the lung at the time of study entry or in the near future.\nKnown or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation and stable without steroid treatment for at least 4 weeks prior to the first dose of study medication.\nPatients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\nPatients who are pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test performed within 7 days before the onset of treatment(Appendix 8).\n\nPatients receiving the following classes of inhibitors of CYP3A4 (see Appendix 5 for guidelines and wash out periods):\n\nAzole antifungals\nMacrolide antibiotics\nProtease inhibitors\nConcomitant use of known CYP3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.\nMajor surgery within 2 weeks of starting study treatment; patients must have recovered from any effects of any major surgery.\nSignificant weight loss (= 10% of body weight) in the 6 weeks before inclusion in the study.\nAny condition that is unstable or could endanger the patient's safety and/or the patient's compliance with the study.\nSubstance abuse or clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance.\nPatients who present any contraindication or suspected allergy to the products under investigation in the study. Tablets of gefitinib contain lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose and galactose malabsorption, will not be included in this trial.\nContraindication for steroid use.\nImpossibility to comply with treatment due to cultural or geographic circumstances.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Maria Rosario García Campelo, MD",
                "OverallOfficialAffiliation":"Hospital Teresa Herrera",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"H. Germans Trias i Pujol",
                "LocationCity":"Badalona",
                "LocationState":"Barcelona",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"ICO Hospitalet",
                "LocationCity":"Hospitalet",
                "LocationState":"Barcelona",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"H. Gen. Universitario de Alicante",
                "LocationCity":"Alicante",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"H. Vall d'Hebrón",
                "LocationCity":"Barcelona",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"H. Teresa Herrera",
                "LocationCity":"La Coruña",
                "LocationCountry":"Spain"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Spanish Lung Cancer Group website",
                "SeeAlsoLinkURL":"http://www.gecp.org"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000077156",
                "InterventionMeshTerm":"Gefitinib"
              },{
                "InterventionMeshId":"C000531550",
                "InterventionMeshTerm":"Olaparib"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              },{
                "InterventionAncestorId":"D000047428",
                "InterventionAncestorTerm":"Protein Kinase Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000067856",
                "InterventionAncestorTerm":"Poly(ADP-ribose) Polymerase Inhibitors"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M240950",
                "InterventionBrowseLeafName":"Olaparib",
                "InterventionBrowseLeafAsFound":"Olaparib",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M1679",
                "InterventionBrowseLeafName":"Gefitinib",
                "InterventionBrowseLeafAsFound":"Gefitinib",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M24407",
                "InterventionBrowseLeafName":"Protein Kinase Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M205",
                "InterventionBrowseLeafName":"Poly(ADP-ribose) Polymerase Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008175",
                "ConditionMeshTerm":"Lung Neoplasms"
              },{
                "ConditionMeshId":"D000002289",
                "ConditionMeshTerm":"Carcinoma, Non-Small-Cell Lung"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012142",
                "ConditionAncestorTerm":"Respiratory Tract Neoplasms"
              },{
                "ConditionAncestorId":"D000013899",
                "ConditionAncestorTerm":"Thoracic Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000008171",
                "ConditionAncestorTerm":"Lung Diseases"
              },{
                "ConditionAncestorId":"D000012140",
                "ConditionAncestorTerm":"Respiratory Tract Diseases"
              },{
                "ConditionAncestorId":"D000002283",
                "ConditionAncestorTerm":"Carcinoma, Bronchogenic"
              },{
                "ConditionAncestorId":"D000001984",
                "ConditionAncestorTerm":"Bronchial Neoplasms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9755",
                "ConditionBrowseLeafName":"Lung Neoplasms",
                "ConditionBrowseLeafAsFound":"Lung Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M4128",
                "ConditionBrowseLeafName":"Carcinoma, Non-Small-Cell Lung",
                "ConditionBrowseLeafAsFound":"Non-Small Cell Lung Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M4116",
                "ConditionBrowseLeafName":"Carcinoma",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13562",
                "ConditionBrowseLeafName":"Respiratory Tract Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15241",
                "ConditionBrowseLeafName":"Thoracic Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9751",
                "ConditionBrowseLeafName":"Lung Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13560",
                "ConditionBrowseLeafName":"Respiratory Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4122",
                "ConditionBrowseLeafName":"Carcinoma, Bronchogenic",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3842",
                "ConditionBrowseLeafName":"Bronchial Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC08",
                "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}