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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

Tracking Information
First Submitted Date  ICMJE February 26, 2010
First Posted Date  ICMJE March 5, 2010
Results First Submitted Date  ICMJE November 12, 2012
Results First Posted Date  ICMJE December 10, 2012
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE February 4, 2010
Actual Primary Completion Date October 10, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2010)
Progression free survival [ Time Frame: Event driven primary outcome, approx. 19 months after recruitment is open ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2010)
  • Percentage Change in Tumour Size [ Time Frame: 9 weeks after recruitment of the 50th patient ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
    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
  • Drug: paclitaxel
    175mg/m2 iv for up to 6 cycles (18 weeks)
  • Drug: Drug: carboplatin
    AUC4 iv for up to 6 cycles (18 weeks)
Study Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: September 12, 2017)
162
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2010)
150
Estimated Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date October 10, 2011   (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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 125 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czechia,   Germany,   Italy,   Japan,   Netherlands,   Panama,   Peru,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01081951
Other Study ID Numbers  ICMJE D0810C00041
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Amit Oza, MD Princess Margaret Hospital, Canada
PRS Account AstraZeneca
Verification Date September 2020

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