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

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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)

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

Trial contacts and locations

42

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Data sourced from clinicaltrials.gov

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