Overview

This trial is active, not recruiting.

Condition ovarian cancer
Treatments olaparib, paclitaxel, carboplatin, drug: carboplatin
Phase phase 2
Target PARP
Sponsor AstraZeneca
Start date February 2010
End date October 2011
Trial size 173 participants
Trial identifier NCT01081951, D0810C00041

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
200mg, 400mg BID - CAPSULES Olaparib paclitaxel iv and carboplatin iv
olaparib
Oral dose capsule 200mg BID day 1-10 of every 21 day cycle, Oral dose capsule 400mg BID continuously after completion of combination therapy
paclitaxel
175mg/m2 iv for up to 6 cycles (18 weeks)
drug: carboplatin
AUC4 iv for up to 6 cycles (18 weeks)
(Active Comparator)
paclitaxel iv and carboplatin iv
paclitaxel Taxol
175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
carboplatin
AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle

Primary Outcomes

Measure
Progression Free Survival (PFS)
time frame: Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months)
Percentage Change in Tumour Size
time frame: Week 9 (+/- 1 week)

Eligibility Criteria

Female participants from 18 years up to 125 years old.

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

Additional Information

Official title A Phase II Open Label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients With Platinum Sensitive Advanced Serous Ovarian Cancer
Principal investigator Amit Oza, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.