Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01081951
Recruitment Status : Active, not recruiting
First Posted : March 5, 2010
Results First Posted : December 10, 2012
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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 ...

Layout table for study information
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, 2020


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




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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

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


Locations
Layout table for location information
United States, California
Research Site
Los Angeles, California, United States, 90048
Research Site
Stanford, California, United States, 94305
United States, Florida
Research Site
Orlando, Florida, United States, 32806
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02114
Research Site
Boston, Massachusetts, United States, 02215
United States, Oregon
Research Site
Portland, Oregon, United States, 97227-1191
Australia
Research Site
Parkville, Australia, 3050
Research Site
Randwick, Australia, 2031
Belgium
Research Site
Brussels, Belgium, 1090
Research Site
Leuven, Belgium, 3000
Research Site
Namur, Belgium, 5000
Research Site
Wilrijk, Belgium, 2610
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Research Site
Hamilton, Ontario, Canada, L8V 5C2
Research Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Research Site
Sherbrooke, Quebec, Canada, J1H 5N4
Canada
Research Site
Quebec, Canada, G1R 2J6
Czechia
Research Site
Praha 2, Czechia, 120 00
Germany
Research Site
Frankfurt, Germany, 60590
Research Site
Hamburg, Germany, 20246
Research Site
München, Germany, 81675
Research Site
Solingen, Germany, 42653
Italy
Research Site
Genova, Italy, 16132
Research Site
Milan, Italy, 20141
Japan
Research Site
Chuo-ku, Japan, 104-0045
Research Site
Fukuoka-shi, Japan, 811-1395
Research Site
Matsuyama-shi, Japan, 791-0280
Research Site
Morioka-shi, Japan, 020-8505
Research Site
Shinjuku-ku, Japan, 160-8582
Research Site
Yamagata-shi, Japan, 990-9585
Research Site
Yonago-shi, Japan, 683-8504
Netherlands
Research Site
Amsterdam, Netherlands, 1066 CX
Research Site
Nijmegen, Netherlands, 6525 GA
Research Site
Rotterdam, Netherlands, 3015 CE
Panama
Research Site
Ciudad de Panama, Panama, 2723
Peru
Research Site
Lima, Peru, LIMA 27
Research Site
Lima, Peru, LIMA 41
Spain
Research Site
Barcelona, Spain, 08035
Research Site
Valencia, Spain, 46010
United Kingdom
Research Site
Birmingham, United Kingdom, B18 7QH
Research Site
Coventry, United Kingdom, CV2 2DX
Research Site
Edinburgh, United Kingdom, EH4 2XR
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Amit Oza, MD Princess Margaret Hospital, Canada
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01081951    
Other Study ID Numbers: D0810C00041
First Posted: March 5, 2010    Key Record Dates
Results First Posted: December 10, 2012
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
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