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 - Full Text View

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01081951

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:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	150
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 4 cycles (12 weeks) Drug: Drug: carboplatin iv for up to 4 cycles (12 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
Last Updated:	March 29, 2012
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 May 23, 2012