Trial · NCT02502266
Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer
NCT02502266, Phase 2, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer. Trials, record NCT02502266. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02502266
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer
- NCT number
- NCT02502266
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 582 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fallopian Tube Undifferentiated Carcinoma, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Adenocarcinoma, Ovarian Transitional Cell Carcinoma, Ovarian Undifferentiated Carcinoma, Primary Peritoneal Serous Adenocarcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- Interventions
Cediranib, Cediranib Maleate, Computed Tomography, Magnetic Resonance Imaging, Olaparib, Paclitaxel, Pegylated Liposomal Doxorubicin Hydrochloride, Questionnaire Administration, Topotecan, Topotecan Hydrochloride
- First posted
- 2015-07-20
- Last updated
- 2026-10-01
- Results first posted
- 2025-05-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) (Phase II Only) | The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. Approximately 42 months. | Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Primary | Progression-free Survival (PFS) (Phase III Only) | The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. Approximately 42 months. | Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Primary | Overall Survival (OS) (Phase III Only) | Time from study enrollment to death due to any cause, assessed up to 5 years | Overall survival will be evaluated. To allow for better understanding of time to subsequent therapy and OS, patients on experimental study drug(s) or standard chemotherapy arm will be followed after progression, with data capture to include the date of initiation of the subsequent therapy, detailed information on the type of subsequent therapy received, and time to progression on the subsequent therapy. |
| Secondary | Objective Response Rate (Complete Response and Partial Response) (Phase II Only) | Up to 5 years | The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria. A Complete response (CR) is defined as the complete disappearance of all target lesions, while a Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters of target lesions compared to the baseline measurement; essentially, the tumor shrinks significantly but does not completely disappear. Overall response (OR) = CR + PR. |
| Secondary | Objective Response Rate (Complete Response and Partial Response for Phase III Only) | Up to 5 years | The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria. A Complete response (CR) is defined as the complete disappearance of all target lesions, while a Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters of target lesions compared to the baseline measurement; essentially, the tumor shrinks significantly but does not completely disappear. Overall response (OR) = CR + PR. |
| Secondary | Incidence of Grade 3 (or Higher) Adverse Events | Up to 5 years | Adverse events will be categorized by CTCAE V4.0. This outcome will report the count of participants who experienced a grade 3 (or higher) adverse event. |
| Other | Patient-reported Scores of Disease-related Symptoms | Up to 5 years | Measured by the 9-item Disease Related Symptoms (DRS-9) subscale of the National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT) Ovarian Symptom Index (NFOSI-18). |
| Other | Gene Mutations Assessed BROCA-HR | Up to 5 years | A single proportional hazards model will be used to estimate the treatment hazard ratios (and variances) for each of the experimental treatments selected for phase III evaluation relative to the reference treatment (chemotherapy) group. The model will include adjustments for prior platinum-free interval, prior bevacizumab treatment, age at study enrollment, randomly assigned study treatment and BROCA-HR status. The estimated hazard ratio(s) for BROCA-HR and the corresponding confidence intervals will be depicted with a forest plot, and assessed for qualitative interaction(s). |
| Other | Change in Circulating Endothelial Cell Levels | Baseline up to 5 years | A proportional hazards model will be used to assess a linear association between the change in circulating endothelial cell values and the log relative hazard of death within each treatment group. Sensitivity analyses will include known prognostic factors in the model. A plot of the martingale residuals or estimated relative hazards by change in circulating endothelial cell quintiles will be used to qualitatively assess the assumption of a linear relationship between the change in circulating endothelial cell values and the log relative hazard. |
| Other | Biomarkers in Plasma Angiome | Up to 5 years | A proportional hazards model will be used to assess whether the pretreatment values of any of these analytes have a prognostic association with overall survival. The model will include clinical covariates: age, performance status, and the randomly assigned study treatment. Proportional hazards models will be used to assess the relationship between patients' analyte values and log hazard. A proportional hazards model will be used to assess the potential predictive associations between analytes, treatment and survival. |
Source ClinicalTrials.gov
Outcomes10
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) (Phase II Only) | The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. Approximately 42 months. | All subjects randomized at Phase II. | Months | MEDIAN |
| PRIMARY | Progression-free Survival (PFS) (Phase III Only) | The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. Approximately 42 months. | All randomized subjects in Arms I - VII (excluding Arm IV).~Arm 4 (Olaparib alone) was not continued in the Phase III part for its lack of efficacy after the completion of the Phase II portion. No further analyses were performed or reported for this arm.~The primary endpoint analysis also did not include 20 Japanese patients who were enrolled after the primary Phase III endpoint was reached. | months | MEDIAN |
| PRIMARY | Overall Survival (OS) (Phase III Only) | Time from study enrollment to death due to any cause, assessed up to 5 years | All randomized subjects in Arms I - VII (excluding Arm IV).~Arm 4 (Olaparib alone) was not continued in the Phase III part for its lack of efficacy after the completion of the Phase II portion. No further analyses were performed or reported for this arm.~Twenty Japanese patients who were enrolled after the primary Phase III endpoint was reached were not included in the analysis for overall survival. | months | MEDIAN |
| SECONDARY | Objective Response Rate (Complete Response and Partial Response) (Phase II Only) | Up to 5 years | Patients randomized at phase II and with measurable disease. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (Complete Response and Partial Response for Phase III Only) | Up to 5 years | Patients with measurable disease in Arms I - VII (excluding Arm IV).~Arm 4 (Olaparib alone) was not continued in the Phase III part for its lack of efficacy after the completion of the Phase II portion. No further analyses were performed or reported for this arm.~Twenty Japanese patients who were enrolled after the primary Phase III endpoint was reached were not included in the analysis of overall response rates. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Grade 3 (or Higher) Adverse Events | Up to 5 years | Randomized and treated patients in Arms I - VII.~Arm 4 (Olaparib alone) was not continued in the Phase III part for its lack of efficacy after the completion of the Phase II portion. No further analyses were performed or reported for this arm.~Twenty Japanese patients who were enrolled after the primary Phase III endpoint was reached were not included in the analysis of adverse events. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Patient-reported Scores of Disease-related Symptoms | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Gene Mutations Assessed BROCA-HR | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Change in Circulating Endothelial Cell Levels | Baseline up to 5 years | |||
| OTHER_PRE_SPECIFIED | Biomarkers in Plasma Angiome | Up to 5 years |
Source ClinicalTrials.gov
Results by group33
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) (Phase II Only) | Arm I (Reference Regimen) | 2.3 | 95% Confidence Interval 2.1 to 4.2 | Months | |
| Progression-free Survival (PFS) (Phase II Only) | Arm II (Cediranib Maleate, Olaparib) | 6.2 | 95% Confidence Interval 3.9 to 8.2 | Months | |
| Progression-free Survival (PFS) (Phase II Only) | Arm III (Cediranib Maleate) | 3.4 | 95% Confidence Interval 2.3 to 4.8 | Months | |
| Progression-free Survival (PFS) (Phase II Only) | Arm IV (Olaparib) (Phase II Only) | 2.3 | 95% Confidence Interval 2.0 to 2.8 | Months | |
| Progression-free Survival (PFS) (Phase III Only) | Arm I (Reference Regimen) | 3.4 | 95% Confidence Interval 2.4 to 4.3 | months | |
| Progression-free Survival (PFS) (Phase III Only) | Arm II (Cediranib Maleate, Olaparib) | 5.2 | 95% Confidence Interval 4.2 to 6.2 | months | |
| Progression-free Survival (PFS) (Phase III Only) | Arm III (Cediranib Maleate) | 4.0 | 95% Confidence Interval 3.2 to 4.3 | months | |
| Progression-free Survival (PFS) (Phase III Only) | Arm V: (Arm 1 Regimen: JP Patients Enrolled After P3 Cutoff) | 4.2 | 95% Confidence Interval 2.1 to NA | months | |
| Progression-free Survival (PFS) (Phase III Only) | Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff) | 5.3 | 95% Confidence Interval 2.5 to 12.6 | months | |
| Progression-free Survival (PFS) (Phase III Only) | Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff) | 4.1 | 95% Confidence Interval 2.3 to 4.8 | months |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Reference Regimen) | 173 | |
| Overall Study | STARTED | Arm II (Cediranib Maleate, Olaparib) | 167 | |
| Overall Study | STARTED | Arm III (Cediranib Maleate) | 170 | |
| Overall Study | STARTED | Arm IV (Olaparib) (Phase II Only) | 52 | |
| Overall Study | STARTED | Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff) | 5 | |
| Overall Study | STARTED | Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff) | 8 | |
| Overall Study | STARTED | Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff) | 7 | |
| Overall Study | COMPLETED | Arm I (Reference Regimen) | 124 | |
| Overall Study | COMPLETED | Arm II (Cediranib Maleate, Olaparib) | 146 | |
| Overall Study | COMPLETED | Arm III (Cediranib Maleate) | 139 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events2,975
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 | Anemia | Blood and lymphatic system disorders | Arm I (Reference Regimen) | 65 | 156 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Cediranib Maleate, Olaparib) | 35 | 163 | |
| other | Anemia | Blood and lymphatic system disorders | Arm III (Cediranib Maleate) | 22 | 162 | |
| other | Anemia | Blood and lymphatic system disorders | Arm IV (Olaparib) (Phase II Only) | 27 | 49 | |
| other | Anemia | Blood and lymphatic system disorders | Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff) | 1 | 5 | |
| other | Anemia | Blood and lymphatic system disorders | Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff) | 1 | 7 | |
| other | Anemia | Blood and lymphatic system disorders | Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff) | 1 | 7 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm I (Reference Regimen) | 5 | 156 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm II (Cediranib Maleate, Olaparib) | 4 | 163 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm III (Cediranib Maleate) | 1 | 162 |
1 to 10 of 2,975Source ClinicalTrials.gov
See all 2,975 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Reference Regimen) | 137 | 173 |
| Total, all-cause mortality | Arm II (Cediranib Maleate, Olaparib) | 145 | 167 |
| Total, all-cause mortality | Arm III (Cediranib Maleate) | 143 | 170 |
| Total, all-cause mortality | Arm IV (Olaparib) (Phase II Only) | 45 | 52 |
| Total, all-cause mortality | Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff) | 2 | 5 |
| Total, all-cause mortality | Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff) | 5 | 8 |
| Total, all-cause mortality | Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff) | 6 | 7 |
| Total, other adverse events | Arm I (Reference Regimen) | 151 | 156 |
| Total, other adverse events | Arm II (Cediranib Maleate, Olaparib) | 162 | 163 |
| Total, other adverse events | Arm III (Cediranib Maleate) | 162 | 162 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39361946 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02502266
GET https://conductscience.org/api/trials/v1/NCT02502266/results?page=2