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 - Tabular View

Tracking Information

First Received Date ^ICMJE

February 26, 2010

Last Updated Date

July 19, 2011

Start Date ^ICMJE

February 2010

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression free survival [ Time Frame: Event driven primary outcome, approx. 19 months after recruitment is open ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01081951 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage change in tumour size [ Time Frame: 9 weeks after recruitment of the 50th patient ] [ Designated as safety issue: No ]
To compare the safety and tolerability by collection of adverse events, haematology, clinical chemistry data, vital signs [ Time Frame: performed at screening, every week for the first 6 weeks then every 3 weeks thereafter until discontinuation from chemotherapy. Following chemotherapy phase, safety assessments will be performed until disease progression ] [ Designated as safety issue: Yes ]
Overall Survival [ Time Frame: will be collected until ~ 90 deaths occur ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Percentage change in tumour size [ Time Frame: 9 weeks after recruitment of the 50th patient ] [ Designated as safety issue: No ]
To compare the safety and tolerability by collection of adverse events, haematology, clinical chemistry data, vital signs [ Time Frame: performed at screening, every week for the first 6 weeks then every 3 weeks thereafter until discontinuation from chemotherapy. Following chemotherapy phase, safety assessments will be performed until disease progression ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase II

Study Design ^ICMJE

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

Condition ^ICMJE

Ovarian Cancer

Intervention ^ICMJE

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 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
Drug: paclitaxel
iv for up to 4 cycles (12 weeks)
Drug: Drug: carboplatin
iv for up to 4 cycles (12 weeks)

Study Arms

Experimental: 1
200mg, 400mg BID - CAPSULES Olaparib paclitaxel iv and carboplatin iv
Interventions:
- Drug: olaparib
- Drug: paclitaxel
- Drug: Drug: carboplatin
Active Comparator: 2
paclitaxel iv and carboplatin iv
Interventions:
- Drug: paclitaxel
- Drug: carboplatin

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Canada, Czech Republic, Germany, Italy, Japan, Netherlands, Panama, Peru, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01081951

Other Study ID Numbers ^ICMJE

D0810C00041

Has Data Monitoring Committee

Responsible Party

MSD, AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Jane Robertson, BSc, MBCHB, MD	AstraZeneca
Principal Investigator:	Amit Oza, MD	Princess Margaret Hospital, Canada

Information Provided By

AstraZeneca

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP