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

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ClinicalTrials.gov Identifier: NCT01081951

Recruitment Status : Active, not recruiting

First Posted : March 5, 2010

Results First Posted : December 10, 2012

Last Update Posted : February 26, 2019

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer	Drug: olaparib Drug: paclitaxel Drug: carboplatin Drug: Drug: carboplatin	Phase 2

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	162 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Actual Study Start Date :	February 4, 2010
Actual Primary Completion Date :	October 10, 2011
Estimated Study Completion Date :	December 31, 2019

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Ovarian cancer

MedlinePlus related topics: Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin Olaparib

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

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) ]
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) ]
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) ]
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.

Eligibility Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081951

Show 45 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

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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.

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Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01081951 History of Changes
Other Study ID Numbers:	D0810C00041
First Posted:	March 5, 2010 Key Record Dates
Results First Posted:	December 10, 2012
Last Update Posted:	February 26, 2019
Last Verified:	February 2019

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:

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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial	Neoplasms by Histologic Type Paclitaxel Albumin-Bound Paclitaxel Carboplatin Olaparib Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors

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