Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT01081951

This clinical trial evaluates the efficacy of olaparib combined with carboplatin (AUC4) and paclitaxel versus carboplatin (AUC6) and paclitaxel in advanced ovarian cancer patients. Eligible participants must have serous ovarian cancer, a history of up to three platinum treatments, and measurable lesions. Interventions include oral olaparib and intravenous paclitaxel and carboplatin over 18 weeks.

Patient Parameters

Program Overview

To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with serous ovarian cancer
  • Patients who have received no more than 3 previous platinum containing treatments and were progression free for at least 6 months following the end of the last platinum treatment
  • At least one lesion that is suitable for accurate repeated measurements

Exclusion Criteria

  • Patients receiving any systemic anticancer chemotherapy, radiotherapy (except palliative) within two weeks from the last dose prior to study treatment
  • Hypersensitivity to pre medications required for treatment with paclitaxel/carboplatin

Locations

FACILITYZIPCITYSTATE
Research Site94305StanfordCalifornia
Research Site90048West HollywoodCalifornia
Research Site32806OrlandoFlorida
Research Site46202IndianapolisIndiana
Research Site02114BostonMassachusetts
Research Site02215BostonMassachusetts
Research Site10016New YorkNew York
Research Site97227-1191PortlandOregon

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