{
  "FullStudy":{
    "Rank":218023,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513733",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Pro00032421"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"c11-082",
                "SecondaryIdType":"Other Grant/Funding Number",
                "SecondaryIdDomain":"PCCTC"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Duke University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Prostate Cancer",
          "OfficialTitle":"The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Castration-Resistant Heavily Pre-treated Prostate Cancer",
          "Acronym":"CATCH"
        },
        "StatusModule":{
          "StatusVerifiedDate":"August 2018",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2016",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"August 31, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 4, 2018",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"Andrew J. Armstrong, MD",
            "ResponsiblePartyInvestigatorTitle":"Assoc Professor of Medicine",
            "ResponsiblePartyInvestigatorAffiliation":"Duke University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Andrew J. Armstrong, MD",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The standard of care for men with metastatic CRPC in 2010 following progression on docetaxel is cabazitaxel or abiraterone acetate/prednisone. Based on results from two other studies, cabazitaxel and prednisone has become a standard second line chemotherapy regimen and becomes the backbone upon which to improve upon. Thus, the primary objective of this study is to determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC)."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Prostate Cancer"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Non-Randomized",
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"25",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Tasquinimod single dose",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: tasquinimod"
                  ]
                }
              },{
                "ArmGroupLabel":"tasquinimod 0.25 mg followed by 0.5 mg",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: tasquinimod 0.25 mg; 0.5 mg"
                  ]
                }
              },{
                "ArmGroupLabel":"tasquinimod 0.25 mg; 0.5 mg; 1.0 mg",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: tasquinimod 0.25 mg; 0.5 mg; 1.0 mg"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"tasquinimod",
                "InterventionDescription":"tasquinimod 0.25 mg continuously",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Tasquinimod single dose"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"tasquinimod 0.25 mg; 0.5 mg",
                "InterventionDescription":"tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "tasquinimod 0.25 mg followed by 0.5 mg"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"tasquinimod 0.25 mg; 0.5 mg; 1.0 mg",
                "InterventionDescription":"tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "tasquinimod 0.25 mg; 0.5 mg; 1.0 mg"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of participants who experience dose limiting toxicities at the highest titrated dose for each dose level",
                "PrimaryOutcomeDescription":"The primary objective is to determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC).",
                "PrimaryOutcomeTimeFrame":"6 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Evaluation of progression free survival",
                "SecondaryOutcomeDescription":"Preliminary evidence of durable efficacy will be based on a modified PCWG2-defined radiologic progression-free survival including RECIST 1.1 criteria (PFS).",
                "SecondaryOutcomeTimeFrame":"Every 9 weeks"
              },{
                "SecondaryOutcomeMeasure":"Evaluation of overall response",
                "SecondaryOutcomeDescription":"Radiologic response criteria using RECIST 1.1 (overall response)",
                "SecondaryOutcomeTimeFrame":"Every 9 weeks"
              },{
                "SecondaryOutcomeMeasure":"Preliminary evidence of response efficacy as measured by the rates of PSA decline (waterfall plot) and benchmarks of reaching a >30% decline within 3 months, a PSA decline >50% and >90%, and PSA normalization. Duration of PSA responses will be measured",
                "SecondaryOutcomeTimeFrame":"Every 3 weeks"
              },{
                "SecondaryOutcomeMeasure":"Favorable changes in circulating tumor cell number (5 or greater to less than 5) and proportion of men who achieve a reduction in CTC count",
                "SecondaryOutcomeTimeFrame":"Every 3 weeks"
              },{
                "SecondaryOutcomeMeasure":"Number and percent of participants that are alive",
                "SecondaryOutcomeDescription":"Overall survival",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"Detailed characterization of all NCI CTC v4.0 toxicities over time (per cycle)",
                "SecondaryOutcomeDescription":"Detailed characterization of all NCI CTC v4.0 toxicities over time (per cycle)",
                "SecondaryOutcomeTimeFrame":"Every 3 weeks"
              },{
                "SecondaryOutcomeMeasure":"The concentration of tasquinimod and cabazitaxel in blood plasma",
                "SecondaryOutcomeDescription":"Pharmacokinetic analysis of tasquinimod and cabazitaxel (cycle 1-4 only)",
                "SecondaryOutcomeTimeFrame":"12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Pain response, as measured by percentage of patients with a reduction of at least 2 points on the visual analog scale despite a stable pain regimen. Pain scores over time will be described in an exploratory fashion.",
                "SecondaryOutcomeTimeFrame":"Every 3 weeks"
              },{
                "SecondaryOutcomeMeasure":"Changes in bone alkaline phosphatase and LDH over time",
                "SecondaryOutcomeDescription":"Descriptive statistics will be used to summarize laboratory variables",
                "SecondaryOutcomeTimeFrame":"Every 3 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHistologically or cytologically confirmed adenocarcinoma of the prostate without small cell features;\nAt least 18 years of age when signing the Informed Consent;\nPresence of metastatic disease on bone scan or CT/MRI imaging;\nOngoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration);\nFor patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trial;\nSerum testosterone level < 50 ng/dL at the Screening Visit;\nProgressive disease on or following docetaxel-based chemotherapy with medical or surgical castration. Patients who are intolerant of docetaxel are also allowed. Disease progression for study entry is defined as one or more of the following three criteria: 1) PSA progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the Screening visit should be ≥ 2 μg/L (2 ng/mL); 2) Soft tissue disease progression defined by RECIST 1.1; 3) Bone metastatic disease progression defined by one or more new lesions on bone scan that are not clinically consistent with tumor flare;\nNo more than three prior chemotherapy regimens with at least one regimen containing docetaxel (unless intolerant as per # 7 above);\nKarnofsky Performance Status of >70;\nEstimated life expectancy of at least three months;\nAble to swallow the study drug and comply with study requirements;\nWilling and able to give informed consent.\n\nExclusion Criteria:\n\nSubjects > 80 years old (dose escalation phase only, due to lower clearance in elderly patients);\nSevere concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment;\nMetastases in the brain or active epidural disease (NOTE: patients with treated epidural disease are allowed provided follow up imaging documents stability of epidural disease);\nAbsolute neutrophil count < 1,200/μL, platelet count < 100,000/μL, and hemoglobin <9 g/dL at the Screening Visit; (NOTE: patients may not have received any growth factors or blood transfusions within seven days of the hematologic laboratory values obtained at the Screening Visit)\nTotal bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal at the Screening Visit;\nCreatinine > 1.5 x ULN at the Screening visit;\nHistory of another malignancy within the previous 3 years other than non-melanomatous skin cancer or non-invasive bladder cancer treated with curative intent;\nTreatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide, MDV3100), 5-α reductase inhibitors (finasteride, dutasteride), estrogens (ie DES), sipuleucel-T, or chemotherapy within 28 days of Day 1 visit or plans to initiate treatment with any of these treatments during the study;\nUse of herbal products that may decrease PSA levels or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within four weeks of Day 1 visit;\nOngoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4\nExposure to ketoconazole or other strong CYP3A4 inhibitors or inducers intravenously or orally within 28 days prior to Day 1 Visit. For abiraterone acetate or TAK700, 14 days washout is needed.\nOngoing treatment with sensitive CYP1A2 substrates or CYP1A2 substrates with narrow therapeutic range (Appendix 3).\nOngoing treatment with CYP3A4 substrates with narrow therapeutic range (Appendix 3).\nRadiation therapy within 2 weeks (if single fraction of radiotherapy within 2 weeks) and radionuclide therapy within 8 weeks of Day 1 visit;\nPlanned palliative procedures for alleviation of bone pain such as radiation therapy or surgery;\nStructurally unstable bone lesions suggesting impending fracture;\nClinically significant cardiovascular disease including:myocardial infarction within 6 months, uncontrolled angina within 3 months, congestive heart failure, Diagnosed or suspected congenital long QT syndrome; significant ventricular arrhythmias, Prolonged corrected QT interval by the Fridericia or Bazett correction formula, History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place; Hypotension (systolic blood pressure < 86 mMHg or bradycardia with a heart rate < 50 beats per minute on any ECG taken at the Screening or Day 1 visit; Uncontrolled hypertension; TIA or stroke/CVA within 6 months of Day 1 visit; Rest limb claudication or ischemia within 6 months of Day 1 visit\nUse of an investigational agent within four weeks of Day 1 visit or plans to initiate treatment with an investigational agent during the study;\nGastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last three months);\nMajor surgery within four weeks prior to Day 1 visit.\nPresence of NCI CTC grade >1 peripheral neuropathy\nHistory of pancreatitis\nKnown positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host).\nChronic hepatitis B or C with advanced, decompensated hepatic disease, or cirrhosis of the liver or history of a chronic viral hepatitis or known viral hepatitis carrier (patients recovered from hepatitis will be allowed to enter the study).\nDocumented prior disease progression on tasquinimod -",
          "HealthyVolunteers":"No",
          "Gender":"Male",
          "MinimumAge":"18 Years",
          "MaximumAge":"79 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Andrew Armstrong, MD",
                "OverallOfficialAffiliation":"Duke Cancer Institute",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"The University of Chicago",
                "LocationCity":"Chicago",
                "LocationState":"Illinois",
                "LocationZip":"60637",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Duke Cancer Institute",
                "LocationCity":"Durham",
                "LocationState":"North Carolina",
                "LocationZip":"27710",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Duke Cancer Institute",
                "SeeAlsoLinkURL":"http://www.cancer.duke.edu"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000011471",
                "ConditionMeshTerm":"Prostatic Neoplasms"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000005834",
                "ConditionAncestorTerm":"Genital Neoplasms, Male"
              },{
                "ConditionAncestorId":"D000014565",
                "ConditionAncestorTerm":"Urogenital Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000005832",
                "ConditionAncestorTerm":"Genital Diseases, Male"
              },{
                "ConditionAncestorId":"D000011469",
                "ConditionAncestorTerm":"Prostatic Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M12918",
                "ConditionBrowseLeafName":"Prostatic Neoplasms",
                "ConditionBrowseLeafAsFound":"Prostate Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M7529",
                "ConditionBrowseLeafName":"Genital Neoplasms, Male",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15898",
                "ConditionBrowseLeafName":"Urogenital Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7527",
                "ConditionBrowseLeafName":"Genital Diseases, Male",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M12916",
                "ConditionBrowseLeafName":"Prostatic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}