The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
265
Tablets Oral BID
matching placebo bid
Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])
PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. \[Full analysis set (FAS)\]
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.
Overall Survival (OS)
OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive.
Time frame: Follow up every 12 weeks post progression, assessed maximum up to 90 months.
Objective Response Rate (ORR) (According to RECIST)
For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set
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.
Disease Control Rate
Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. \[FAS\]
Time frame: Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).
Duration of Response
Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. \[Responding patients only\]. There were insufficient responses to enable conclusions to be drawn.
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Research Site
Berkeley, California, United States
Research Site
San Francisco, California, United States
Research Site
West Hollywood, California, United States
Research Site
Sunrise, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
New York, New York, United States
...and 97 more locations
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.
Percentage Change From Baseline in Tumour Size at Week 24
Percentage change from baseline to Week 24 in target tumour size.
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.
Best Percentage Change in Cancer Antigen 125 (CA-125) Levels
Best percentage change from baseline in CA-125 level
Time frame: CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.
Best Objective Response
Best overall response from radiologic assessments. \[FAS\]
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.
RECIST and CA-125 Response Separately and Combined
RECIST and CA-125 response separately and combined \[Patients evaluable for either CA-125 response or RECIST response\]
Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.
Time to Earlier of CA-125 or RECIST Progression
Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. \[FAS\]
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.
Improvement Rate for FACT-O Symptom Index (FOSI)
The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. \[Evaluable for FOSI set\]
Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Improvement Rate for Trial Outcome Index (TOI)
The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. \[Evaluable for TOI set\]
Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)
The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. \[Evaluable for FACT-O set\]
Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
FACT-O Symptom Index (FOSI) Time to Worsening
The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. \[Evaluable for FOSI set\]
Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Trial Outcome Index(TOI)Time to Worsening
The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. \[Evaluable for TOI set\]
Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening
The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. \[Evaluable for FACT-O set\]
Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.