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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01081951
First received: February 26, 2010
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Ovarian Cancer
Drug: olaparib
Drug: paclitaxel
Drug: carboplatin
Drug: Drug: carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks therafter relative to the date of randomisation ] [ Designated as safety issue: No ]
    PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression).


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Following disease progression, patients will be contacted every 12 weeks to assess survival status ] [ Designated as safety issue: No ]

    OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.

    There were insufficient events to calculate median OS or perform formal statistical analysis, so the number of patients who died are shown. Subsequent analysis will be performed when data are more mature (after further survival follow-up).


  • Percentage Change in Tumour Size [ Time Frame: Week 9 (+/- 1 week) ] [ Designated as safety issue: No ]
    The total tumour size was defined as the sum of the longest diameters of the target lesions. At week 9, the percentage change in tumour size was calculated as [(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions]*100 for each patient. Imputations were used for missing data where possible.


Enrollment: 173
Study Start Date: February 2010
Estimated Study Completion Date: June 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
200mg, 400mg BID - CAPSULES Olaparib paclitaxel iv and carboplatin iv
Drug: 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
Drug: paclitaxel
iv for up to 6 cycles (18 weeks)
Drug: Drug: carboplatin
iv for up to 6 cycles (18 weeks)
Active Comparator: 2
paclitaxel iv and carboplatin iv
Drug: paclitaxel
iv for 6 cycles (18 weeks) day 1 of 21 day cycle
Other Name: Taxol
Drug: carboplatin
iv for 6 cycles (18 weeks) day 1 of 21 day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081951

  Show 49 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Amit Oza, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01081951     History of Changes
Other Study ID Numbers: D0810C00041
Study First Received: February 26, 2010
Results First Received: November 12, 2012
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Canada: Ethics Review Committee
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Germany: Ethics Commission
Germany: Ministry of Health
Italy: Ethics Committee
Italy: Ministry of Health
Japan: Institutional Review Board
Japan: Ministry of Health, Labor and Welfare
Netherlands: Independent Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Ministry of Health, Welfare and Sport
Panama: Commemorative Institute GORGAS of Studies of Health
Panama: Ministry of Health
Peru: Ethics Committee
Peru: Ministry of Health
Spain: Ethics Committee
Spain: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Institutional Review Board

Keywords provided by AstraZeneca:
Poly(ADP ribose)
polymerisation (PARP)
Platinum sensitive
Advanced Serous Ovarian cancer
olaparib
PARP inhibitors
Platinum Sensitive Advanced Serous Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 15, 2014