Trial · NCT00753545
Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
NCT00753545, Phase 2, Completed, AstraZeneca; results first posted 2013-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer. Trials, record NCT00753545. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00753545
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
- NCT number
- NCT00753545
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 265 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Ovarian Cancer
- Interventions
- AZD2281, matching placebo
- First posted
- 2008-09-16
- Last updated
- 2025-02-03
- Other registries' IDs
- eudract:2008-003439-18
- Results first posted
- 2013-03-11
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) | 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. | 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. \[Full analysis set (FAS)\] |
| Secondary | Overall Survival (OS) | Follow up every 12 weeks post progression, assessed maximum up to 90 months. | 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. |
| Secondary | Objective Response Rate (ORR) (According to RECIST) | 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. | 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 |
| Secondary | Disease Control Rate | Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week). | 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. \[FAS\] |
| Secondary | Duration of Response | 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. | 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. |
| Secondary | Percentage Change From Baseline in Tumour Size at Week 24 | 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. | Percentage change from baseline to Week 24 in target tumour size. |
| Secondary | Best Percentage Change in Cancer Antigen 125 (CA-125) Levels | CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months. | Best percentage change from baseline in CA-125 level |
| Secondary | Best Objective Response | 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 overall response from radiologic assessments. \[FAS\] |
| Secondary | RECIST and CA-125 Response Separately and Combined | 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. | RECIST and CA-125 response separately and combined \[Patients evaluable for either CA-125 response or RECIST response\] |
| Secondary | Time to Earlier of CA-125 or RECIST Progression | 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. | 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. \[FAS\] |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) | 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. | Months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Follow up every 12 weeks post progression, assessed maximum up to 90 months. | Months | MEDIAN | |
| SECONDARY | Objective Response Rate (ORR) (According to RECIST) | 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. | Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate | Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week). | percentage of participants | NUMBER | |
| SECONDARY | Duration of Response | 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. | Months | MEDIAN | |
| SECONDARY | Percentage Change From Baseline in Tumour Size at Week 24 | 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. | Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline. | Percent change in tumour size | LEAST_SQUARES_MEAN |
| SECONDARY | Best Percentage Change in Cancer Antigen 125 (CA-125) Levels | CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months. | A subset of the FAS with baseline and at least 1 follow-up value of CA-125 | percentage of change | MEDIAN |
| SECONDARY | Best Objective Response | 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. | Participants | NUMBER | |
| SECONDARY | RECIST and CA-125 Response Separately and Combined | 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. | Participants | NUMBER | |
| SECONDARY | Time to Earlier of CA-125 or RECIST Progression | 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. | Months | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) | Olaparib 400 mg bd | 8.4 | 95% Confidence Interval 7.4 to 11.5 | Months | |
| Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) | Placebo bd | 4.8 | 95% Confidence Interval 4.0 to 5.5 | Months | |
| Overall Survival (OS) | Olaparib 400 mg bd | 29.8 | 95% Confidence Interval 26.9 to 35.7 | Months | |
| Overall Survival (OS) | Placebo bd | 27.8 | 95% Confidence Interval 24.9 to 33.7 | Months | |
| Objective Response Rate (ORR) (According to RECIST) | Olaparib 400 mg bd | 12.3 | percentage of participants | ||
| Objective Response Rate (ORR) (According to RECIST) | Placebo bd | 4.2 | percentage of participants | ||
| Disease Control Rate | Olaparib 400 mg bd | 53.7 | percentage of participants | ||
| Disease Control Rate | Placebo bd | 25.6 | percentage of participants | ||
| Duration of Response | Olaparib 400 mg bd | 4.2 | 95% Confidence Interval 2.8 to 5.6 | Months | |
| Duration of Response | Placebo bd | 2.3 | 95% Confidence Interval 1.8 to 2.8 | Months |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Olaparib 400 mg bd | 136 | |
| Overall Study | STARTED | Placebo bd | 129 | |
| Overall Study | COMPLETED | Olaparib 400 mg bd | 28 | |
| Overall Study | COMPLETED | Placebo bd | 11 | |
| Overall Study | NOT COMPLETED | Olaparib 400 mg bd | 108 | |
| Overall Study | NOT COMPLETED | Placebo bd | 118 |
Source ClinicalTrials.gov
Adverse events192
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Olaparib 400 mg bd | 26 | 136 | 32 |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo | 7 | 128 | 8 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Olaparib 400 mg bd | 7 | 136 | 8 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Placebo | 5 | 128 | 7 |
| other | ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Olaparib 400 mg bd | 6 | 136 | 7 |
| other | ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Placebo | 7 | 128 | 7 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Olaparib 400 mg bd | 21 | 136 | 24 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Placebo | 11 | 128 | 13 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Olaparib 400 mg bd | 35 | 136 | 44 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Placebo | 34 | 128 | 51 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olaparib 400 mg bd | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Olaparib 400 mg bd | 129 | 136 |
| Total, other adverse events | Placebo | 111 | 128 |
| Total, serious adverse events | Olaparib 400 mg bd | 31 | 136 |
| Total, serious adverse events | Placebo | 11 | 128 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Olaparib 400 mg bd vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00753545
GET https://conductscience.org/api/trials/v1/NCT00753545/results?page=2