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

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

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)
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
[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)

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 ]

2.  Secondary:

Overall Survival (OS)   [ Time Frame: Follow up every 8 weeks post progression ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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.