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

Purpose

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.

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:

Genetics Home Reference related topics: ovarian cancer

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin Olaparib

Genetic and Rare Diseases Information Center resources: Ovarian Cancer

U.S. FDA Resources

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 thereafter relative to the date of randomisation until the primary analysis (approximately 20 months) ] [ 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 until the final analysis (approximately 50 months) ] [ 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.
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:	December 2016
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 175mg/m2 iv for up to 6 cycles (18 weeks) Drug: Drug: carboplatin AUC4 iv for up to 6 cycles (18 weeks)
Active Comparator: 2 paclitaxel iv and carboplatin iv	Drug: paclitaxel 175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle Other Name: Taxol Drug: carboplatin AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle

Eligibility


Ages Eligible for Study:	18 Years to 125 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081951

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Sponsors and Collaborators

AstraZeneca

Investigators


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

More Information

Additional Information:

CSR-D0810C00041.pdf This link exits the ClinicalTrials.gov site

Redacted Protocol This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gunderson CC, Moore KN. PARP inhibition in ovarian cancer: state of the science. Gynecol Oncol. 2015 Jan;136(1):8-10. doi: 10.1016/j.ygyno.2014.12.009.

Oza AM, Cibula D, Benzaquen AO, Poole C, Mathijssen RH, Sonke GS, Colombo N, Špaček J, Vuylsteke P, Hirte H, Mahner S, Plante M, Schmalfeldt B, Mackay H, Rowbottom J, Lowe ES, Dougherty B, Barrett JC, Friedlander M. Olaparib combined with chemotherapy for recurrent platinum-sensitive ovarian cancer: a randomised phase 2 trial. Lancet Oncol. 2015 Jan;16(1):87-97. doi: 10.1016/S1470-2045(14)71135-0. Epub 2014 Dec 4. Erratum in: Lancet Oncol. 2015 Jan;16(1):e6. Lancet Oncol. 2015 Feb;16(2):e55.


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:	August 24, 2016
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 Paclitaxel	Olaparib Albumin-Bound Paclitaxel Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 29, 2016