A randomized multicentre phase II trial with pazopanib and weekly paclitaxel vs weekly paclitaxel in platinum resistant or refractory ovarian cancer

INTERVENTION: Product Name: pazopanib Pharmaceutical Form: Tablet INN or Proposed INN: pazopanib Current Sponsor code: GW786034B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: PACLITAXEL TEVA*EV 50ML 6MG/ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: Paclitaxel Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6‐ CONDITION: platinum resistant or refractory ovarian cancer ; MedDRA version: 9.1 Level: LLT Classification code 10033130 PRIMARY OUTCOME: Main Objective: To assess the activity of a combination of pazopanib and weekly paclitaxel compared to weekly paclitaxel in terms of progression‐free survival (PFS). Primary end point(s): PROGRESSION FREE SURVIVAL Secondary Objective: To assess: ?Toxicity ?Response rate ?Overall survival (OAS) INCLUSION CRITERIA: ? Cytologic / histologic diagnosis of stage IC‐IV ovarian cancer ? Disease progressed during first line chemotherapy or disease relapsed within 6 months after the last platinum treatment ? Disease evaluable by RECIST or Ca 125 GCIG criteria ? No residual peripheral neurotoxicity from previous chemotherapy treatment ? PS 0‐1 ? Age ? 18 and < 75 years. ? Life expectancy of at least 3 months ? Able to swallow and retain oral medication ? Written informed consent prior to performance of study specific procedures or assessments ? Ability and willingness to comply with treatment and follow up assessments and procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range