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

AstraZeneca

Status and phase: Active, not recruiting; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: Drug: carboplatin; Drug: carboplatin; Drug: olaparib; Drug: paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01081951

2009-015970-36 (EudraCT Number)

D0810C00041

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: Female

Ages: 18 to 125 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

1

Experimental group

Description:

Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions.

Treatment:

Drug: paclitaxel

Drug: paclitaxel

Drug: olaparib

Drug: Drug: carboplatin

2

Active Comparator group

Description:

paclitaxel iv and carboplatin iv

Treatment:

Drug: paclitaxel

Drug: paclitaxel

Drug: carboplatin