{
  "FullStudy":{
    "Rank":218142,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512186",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2009-016675-29"
          },
          "Organization":{
            "OrgFullName":"Queen Mary University of London",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"A Phase II Study Investigating Upfront Pazopanib In Metastatic Renal Cancer Renal Cancer (Panther)",
          "OfficialTitle":"A Phase II Study Investigating Upfront Pazopanib In Metastatic Clear Cell Renal Cancer (Panther)",
          "Acronym":"Panther"
        },
        "StatusModule":{
          "StatusVerifiedDate":"June 2014",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"July 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2014",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"October 4, 2011",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"June 11, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"June 12, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Centre of Experimental Medicine",
            "ResponsiblePartyInvestigatorTitle":"Thomas Powles",
            "ResponsiblePartyInvestigatorAffiliation":"Queen Mary University of London"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Queen Mary University of London",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to investigate if 14 weeks of pazopanib therapy prior to surgery (nephrectomy) is of benefit to patients with metastatic renal cancer. Ninety-five patients will be recruited into his study.",
          "DetailedDescription":"This is a Phase II, open label study evaluating pre-operative pazopanib treatment in previously untreated patients with metastatic clear cell renal cancer. This study follows a Simon 2 stage design\n\nPatients will take pazopanib for 14 weeks followed by a nephrectomy. The drug will continue after nephrectomy until disease progression is documented. Patients will come off study once disease progression occurs, where they will then be followed for survival. Subsequent treatment at the discretion of the treating physician will be documented.\n\nAfter surgery, all patients will be radiologically evaluated 8 weekly until progression. Standard radical nephrectomy with lymph node dissection will be performed on those patients who are deemed operable. The surgery can be laparoscopic or open. Those not deemed suitable for nephrectomy after 14 weeks of treatment will be offered a repeat biopsy."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Metastatic Clear Cell Renal Cancer"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Clear cell renal cancer"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Only"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"Pre-treatment biopsy and post treatment nephrectomy samples will be obtained"
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"95",
            "EnrollmentType":"Anticipated"
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Clinical benefit of 14 weeks of pre-operative pazopanib therapy, prior to nephrectomy using RECIST 1.1 criteria",
                "PrimaryOutcomeDescription":"12 week CT scan will be compared to the baseline CT scan using RESIST criteria 1.1 to assess whether the patients have benefited from the upfront pazopanib treatment.",
                "PrimaryOutcomeTimeFrame":"Interim analysis after 34 patients have 12 weeks of treatment"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Surgical complications (blood loss, post operative complications, hospital stay)",
                "SecondaryOutcomeDescription":"Following surgery information regarding the quantity of blood loss, time the surgery took, length of hospital stay and whether there were any surgical complications will be recorded.",
                "SecondaryOutcomeTimeFrame":"After the first 20 patients have had a nephrectomy"
              },{
                "SecondaryOutcomeMeasure":"Overall Survival",
                "SecondaryOutcomeDescription":"Overall survival will be measured from start of treatment to time of death.",
                "SecondaryOutcomeTimeFrame":"After three years of study"
              },{
                "SecondaryOutcomeMeasure":"Progression free survival",
                "SecondaryOutcomeDescription":"Progression free survival will be measured from start of study treatment to time of disease progression.",
                "SecondaryOutcomeTimeFrame":"After all patients have progresssed"
              },{
                "SecondaryOutcomeMeasure":"Local response of primary tumour to pazopanib",
                "SecondaryOutcomeTimeFrame":"After 12 weeks of study drug"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHistopathologically confirmed clear cell carcinoma with measurable metastases on CT/MRI imaging (by RECIST v1.1). Only a component of clear cell is required.\n\nNo prior systemic treatment or nephrectomy for RCC. Palliative radiotherapy is acceptable to non target lesions.\n\nAdequate organ function as defined by the following criteria:\n\ni. Total serum bilirubin ≤1.5 x uln (patients with gilbert's disease exempt) ii. Serum transaminases (ALT) <3 x uln iii. Calculated creatinine clearance >30ml/min iv. Absolute neutrophil count (ANC) ≥1000/mm3 without growth factor support v. Platelets ≥ 75,000/mm3\n\nSigned and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment.\nWillingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures\nECOG performance status of 0, 1 or 2.\n18 years or above (no upper age limit) Male or female\n\nExclusion Criteria:\n\nCongestive heart failure (class III or IV NYHA), myocardial infarction or coronary artery bypass graft/ stenting or stroke in the previous six months, ongoing severe or unstable arrhythmia requiring medication.\n\nPrevious treatment for renal cancer\nPregnancy or breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use adequate contraception during the period of therapy.\nMale patients must be surgically sterile or agree to use adequate contraception during the period of therapy.\nOther severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would in the judgement of the investigator, impart excess risk associated with study participation or study drug administration, or which, in the judgement of the investigator, would make the patient inappropriate for entry into this study\nProlonged QT interval >480msecs or a history of prolonged QT interval >480msecs\nOngoing major gastrointestinal disease including ulcerative colitis, bleeding peptic ulcer disease or inflammatory bowel disease.\nBleeding diathesis\nCurrent uncontrolled hypertension\nAnother malignancy requiring treatment within the last 5 years. Local prostate cancer not requiring hormone therapy or an asymptomatic raised PSA is acceptable.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"The study population for this trial are patients with confirmed clear cell carcinoma with measurable metastases on CT/MRI imaging (by RECIST). Only a component of clear cell is required.",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Basildon and Thurrock University Hospitals NHS Foundation Trust",
                "LocationCity":"Basildon",
                "LocationCountry":"United Kingdom"
              },{
                "LocationFacility":"University Hospitals Coventry & Warwickshire NHS Trust",
                "LocationCity":"Coventry",
                "LocationCountry":"United Kingdom"
              },{
                "LocationFacility":"The Beatson West of Scotland Cancer Centre",
                "LocationCity":"Glasgow",
                "LocationCountry":"United Kingdom"
              },{
                "LocationFacility":"Barts and London Hospital NHS Trust",
                "LocationCity":"London",
                "LocationCountry":"United Kingdom"
              },{
                "LocationFacility":"Oncology & Clinical Haematology Trials Unit, Royal Free Hospital",
                "LocationCity":"London",
                "LocationCountry":"United Kingdom"
              },{
                "LocationFacility":"Oncology & Haematology Clinical Trials Unit, Guy's Hospital",
                "LocationCity":"London",
                "LocationCountry":"United Kingdom"
              },{
                "LocationFacility":"Department of Oncology Oxford Cancer Centre",
                "LocationCity":"Oxford",
                "LocationCountry":"United Kingdom"
              },{
                "LocationFacility":"Southampton General Hospital",
                "LocationCity":"Southampton",
                "LocationCountry":"United Kingdom"
              },{
                "LocationFacility":"Southend University Hospital Trust",
                "LocationCity":"Southend",
                "LocationCountry":"United Kingdom"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000007680",
                "ConditionMeshTerm":"Kidney Neoplasms"
              },{
                "ConditionMeshId":"D000002292",
                "ConditionMeshTerm":"Carcinoma, Renal Cell"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000014571",
                "ConditionAncestorTerm":"Urologic Neoplasms"
              },{
                "ConditionAncestorId":"D000014565",
                "ConditionAncestorTerm":"Urogenital Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000007674",
                "ConditionAncestorTerm":"Kidney Diseases"
              },{
                "ConditionAncestorId":"D000014570",
                "ConditionAncestorTerm":"Urologic Diseases"
              },{
                "ConditionAncestorId":"D000000230",
                "ConditionAncestorTerm":"Adenocarcinoma"
              },{
                "ConditionAncestorId":"D000002277",
                "ConditionAncestorTerm":"Carcinoma"
              },{
                "ConditionAncestorId":"D000009375",
                "ConditionAncestorTerm":"Neoplasms, Glandular and Epithelial"
              },{
                "ConditionAncestorId":"D000009370",
                "ConditionAncestorTerm":"Neoplasms by Histologic Type"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M4130",
                "ConditionBrowseLeafName":"Carcinoma, Renal Cell",
                "ConditionBrowseLeafAsFound":"Renal Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9286",
                "ConditionBrowseLeafName":"Kidney Neoplasms",
                "ConditionBrowseLeafAsFound":"Renal Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M4116",
                "ConditionBrowseLeafName":"Carcinoma",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15903",
                "ConditionBrowseLeafName":"Urologic Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15898",
                "ConditionBrowseLeafName":"Urogenital Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9281",
                "ConditionBrowseLeafName":"Kidney Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15902",
                "ConditionBrowseLeafName":"Urologic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M2166",
                "ConditionBrowseLeafName":"Adenocarcinoma",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10903",
                "ConditionBrowseLeafName":"Neoplasms, Glandular and Epithelial",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10898",
                "ConditionBrowseLeafName":"Neoplasms by Histologic Type",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T4931",
                "ConditionBrowseLeafName":"Renal Cell Carcinoma",
                "ConditionBrowseLeafAsFound":"Renal Cancer",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}