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

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ClinicalTrials.gov Identifier: NCT00753545
Recruitment Status : Active, not recruiting
First Posted : September 16, 2008
Results First Posted : September 29, 2011
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ovarian Cancer
Interventions: Drug: AZD2281
Drug: matching placebo

  Participant Flow

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   28 [2]   11 [2] 
NOT COMPLETED   108   118 
Death                98                112 
Lost to Follow-up                2                3 
Protocol Violation                1                0 
Voluntary Discontinuation of Patient                7                3 
[1] Patients randomized
[2] Patients completing the Study



  Baseline Characteristics

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 
Overall Participants Analyzed 
[Units: Participants]
 		 136   129   265 
Age 
[Units: Years]
Mean (Standard Deviation) 		 58.9  (10.95)   58.5  (9.89)   58.7  (10.43) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      136 100.0%      129 100.0%      265 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Time to progression [1] 
[Units: Participants]
 		     
>6 to 12 months   53   54   107 
>12 months   83   75   158 
[1] The time to disease progression from the completion of the penultimate platinum containing therapy (last dose) prior to enrolment on the study.
Objective response [1] 
[Units: Participants]
 		     
Complete response   57   63   120 
Partial response   79   66   145 
[1]

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

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, assessed maximum up to 14 months. ]
  Show Outcome Measure 1

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Follow up every 12 weeks post progression, assessed maximum up to 90 months. ]
  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, assessed maximum up to 14 months. ]
  Show Outcome Measure 3

4.  Secondary:   Disease Control Rate   [ Time Frame: Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week). ]
  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, assessed maximum up to 14 months. ]
  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, assessed maximum up to 14 months. ]
  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, assessed maximum up to 14 months. ]
  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, assessed maximum up to 14 months. ]
  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, assessed maximum up to 14 months. ]
  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, assessed maximum up to 14 months. ]
  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, assessed maximum up to 14 months. ]
  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, assessed maximum up to 14 months. ]
  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, assessed maximum up to 14 months. ]
  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, assessed maximum up to 14 months. ]
  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, assessed maximum up to 14 months. ]
  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, assessed maximum up to 14 months. ]
  Show Outcome Measure 16


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Elizabeth Lowe
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@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
First Submitted: September 12, 2008
First Posted: September 16, 2008
Results First Submitted: December 7, 2012
Results First Posted: September 29, 2011
Last Update Posted: April 18, 2018