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Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00753545
First received: September 12, 2008
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
Results First Received: December 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ovarian Cancer
Interventions: Drug: AZD2281
Drug: matching placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first patient was enrolled on 28 August 2008 and the last patient was enrolled on 9 February 2010. Patients were enrolled at 82 centres in 16 countries. Of the 326 patients enrolled, 265 were randomized

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
It was planned that 250 women with advanced platinum sensitive serous ovarian cancer who had received 2 or more previous platinum-containing regimens and demonstrated an objective stable maintained response in the last platinum regimen prior to enrolment were to receive olaparib 400 mg bd or matching placebo in a 1:1 ratio. 265 randomised.

Reporting Groups
  Description
Olaparib 400 mg bd

AZD2281

Olaparib (AZD2281) 400 mg oral capsules twice daily
Placebo bd Olaparib matching placebo oral capsules twice daily

Participant Flow:   Overall Study
    Olaparib 400 mg bd     Placebo bd  
STARTED     136 [1]   129 [1]
COMPLETED     68 [2]   21 [2]
NOT COMPLETED     68     108  
Adverse Event                 3                 2  
Lack of Efficacy                 54                 93  
Withdrawal by Subject                 9                 8  
Lost to Follow-up                 1                 0  
Protocol Violation                 0                 1  
Not specified                 1                 3  
Consent withrawn prior to treatment                 0                 1  
[1] Patients randomized
[2] Ongoing study treatment at time of data cut-off



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Olaparib 400 mg bd

AZD2281

Olaparib (AZD2281) 400 mg oral capsules twice daily
Placebo bd Olaparib matching placebo oral capsules twice daily
Total Total of all reporting groups

Baseline Measures
    Olaparib 400 mg bd     Placebo bd     Total  
Number of Participants  
[units: participants]
 		  136     129     265  
Age  
[units: years]
Mean (Standard Deviation) 		  58.9  (10.95)     58.5  (9.89)     58.7  (10.43)  
Gender  
[units: participants]
 		     
Female     136     129     265  
Male     0     0     0  
Time to progression [1]
[units: participants]
 		     
>6 to 12 months     53     54     107  
>12 months     83     75     158  
Objective response [2]
[units: Participants]
 		     
Complete response     57     63     120  
Partial response     79     66     145  
[1] The time to disease progression from the completion of the penultimate platinum containing therapy (last dose) prior to enrolment on the study.
[2]

Objective response to the last platinum containing regimen prior to enrolment on the study:

  • CR-Complete Response (defined as normal radiological findings and CA-125 within the normal range)
  • PR-Partial Response (defined as a RECIST PR and/or GCIG CA-125 response)



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])   [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter ]
  Show Outcome Measure 1

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Follow up every 8 weeks post progression ]
  Show Outcome Measure 2

3.  Secondary:   Objective Response Rate (ORR) (According to RECIST)   [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter ]
  Show Outcome Measure 3

4.  Secondary:   Disease Control Rate   [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter ]
  Show Outcome Measure 4

5.  Secondary:   Duration of Response   [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter ]
  Show Outcome Measure 5

6.  Secondary:   Percentage Change From Baseline in Tumour Size at Week 24   [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter ]
  Show Outcome Measure 6

7.  Secondary:   Best Percentage Change in Cancer Antigen 125 (CA-125) Levels   [ Time Frame: CA-125 was measured at baseline then every 28 days on treatment ]
  Show Outcome Measure 7

8.  Secondary:   Best Objective Response   [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter ]
  Show Outcome Measure 8

9.  Secondary:   RECIST and CA-125 Response Separately and Combined   [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements ]
  Show Outcome Measure 9

10.  Secondary:   Time to Earlier of CA-125 or RECIST Progression   [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements ]
  Show Outcome Measure 10

11.  Secondary:   Improvement Rate for FACT-O Symptom Index (FOSI)   [ Time Frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression ]
  Show Outcome Measure 11

12.  Secondary:   Improvement Rate for Trial Outcome Index (TOI)   [ Time Frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression ]
  Show Outcome Measure 12

13.  Secondary:   Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)   [ Time Frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression ]
  Show Outcome Measure 13

14.  Secondary:   FACT-O Symptom Index (FOSI) Time to Worsening   [ Time Frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression ]
  Show Outcome Measure 14

15.  Secondary:   Trial Outcome Index(TOI)Time to Worsening   [ Time Frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression ]
  Show Outcome Measure 15

16.  Secondary:   Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening   [ Time Frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression ]
  Show Outcome Measure 16


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
For OM DoR: The subset of patients evaluable for response who responded to study treatment.Values in results table may be under-estimates as some patients had not progressed at final analysis,so true duration is likely to be greater than in database.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


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


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00753545     History of Changes
Other Study ID Numbers: D0810C00019
Study First Received: September 12, 2008
Results First Received: December 7, 2012
Last Updated: February 6, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration