Trial · NCT02446600
Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT02446600, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2021-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Trials, record NCT02446600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02446600
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- NCT number
- NCT02446600
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 579 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fallopian Tube Undifferentiated Carcinoma, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Tumor, Ovarian Seromucinous Carcinoma, Ovarian Serous Tumor, Ovarian Transitional Cell Carcinoma, Ovarian Undifferentiated Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Ovarian Endometrioid Adenocarcinoma, Recurrent Primary Peritoneal Carcinoma
- Interventions
Biospecimen Collection, Carboplatin, Cediranib Maleate, Computed Tomography, Echocardiography Test, Gemcitabine, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Multigated Acquisition Scan, Olaparib, Paclitaxel, Pegylated Liposomal Doxorubicin Hydrochloride, Pharmacological Study, Quality-of-Life Assessment
- First posted
- 2015-05-18
- Last updated
- 2026-10-01
- Results first posted
- 2021-03-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria | 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. An average of approximately 10 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. Japanese cohort not included in progression free survival analysis, only included in toxicity assessments. |
| Secondary | Overall Survival | Approximately 30 months | Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Japanese cohort not included in overall survival analysis, the cohort was only included in toxicity assessments. |
| Secondary | Frequency and Severity of Adverse Effects | During treatment period and up to 100 days after stopping the study treatment, up to 39 months. | Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy, by Preferred term with incidence rate greater than 5%. |
| Secondary | Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical | Prior to cycle 1, week 12, week 24, week 36, week 48, week 60, week 72, week 84, week 96 and 108 weeks after starting treatment | Disease-related physical symptoms were measured by the Disease-Related Symptom-Physical (DRS-P) subscale of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NCCN/FOSI-18). The DRS-P subscale is composed of 9 items. For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The DRS-P score ranges 0-36 with a larger score suggesting better QOL (Quality of Life) or less symptoms. This analysis did not include the Japanese cohort. |
| Other | Time From Randomization to the First Non-study, Anti-cancer Treatment or Death | Up to 5 years | |
| Other | Time From Randomization to the Second Non-study, Anti-cancer Treatment or Death | Up to 5 years |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria | 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. An average of approximately 10 months. | All Randomized subjects | months | MEDIAN |
| SECONDARY | Overall Survival | Approximately 30 months | All randomized subjects | months | MEDIAN |
| SECONDARY | Frequency and Severity of Adverse Effects | During treatment period and up to 100 days after stopping the study treatment, up to 39 months. | Treated with randomized therapy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical | Prior to cycle 1, week 12, week 24, week 36, week 48, week 60, week 72, week 84, week 96 and 108 weeks after starting treatment | Subjects who have completed baseline and at least one follow-up assessment. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Time From Randomization to the First Non-study, Anti-cancer Treatment or Death | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Time From Randomization to the Second Non-study, Anti-cancer Treatment or Death | Up to 5 years |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria | Arm I (Platinum-based Chemotherapy) | 10.3 | 95% Confidence Interval 8.7 to 11.2 | months | |
| Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria | Arm II (Olaparib) | 8.2 | 95% Confidence Interval 6.6 to 8.7 | months | |
| Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria | Arm III (Olaparib, Cediranib Maleate) | 10.4 | 95% Confidence Interval 8.5 to 12.5 | months | |
| Overall Survival | Arm I (Platinum-based Chemotherapy) | 31.3 | 95% Confidence Interval 26.4 to 34.4 | months | |
| Overall Survival | Arm II (Olaparib) | 29.2 | 95% Confidence Interval 23.9 to 32.7 | months | |
| Overall Survival | Arm III (Olaparib, Cediranib Maleate) | 30.5 | 95% Confidence Interval 27.0 to 36.5 | months | |
| Frequency and Severity of Adverse Effects | Arm I (Platinum-based Chemotherapy) | Anemia | 23 | Participants | |
| Frequency and Severity of Adverse Effects | Arm II (Olaparib) | Anemia | 28 | Participants | |
| Frequency and Severity of Adverse Effects | Arm III (Olaparib, Cediranib Maleate) | Anemia | 11 | Participants | |
| Frequency and Severity of Adverse Effects | Japanese Cohort | Anemia | 1 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Platinum-based Chemotherapy) | 187 | |
| Overall Study | STARTED | Arm II (Olaparib) | 190 | |
| Overall Study | STARTED | Arm III (Olaparib, Cediranib Maleate) | 189 | |
| Overall Study | STARTED | Japanese Cohort | 13 | |
| Overall Study | COMPLETED | Arm I (Platinum-based Chemotherapy) | 147 | |
| Overall Study | COMPLETED | Arm II (Olaparib) | 178 | |
| Overall Study | COMPLETED | Arm III (Olaparib, Cediranib Maleate) | 162 | |
| Overall Study | COMPLETED | Japanese Cohort | 12 | |
| Overall Study | NOT COMPLETED | Arm I (Platinum-based Chemotherapy) | 40 | |
| Overall Study | NOT COMPLETED | Arm II (Olaparib) | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,664
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 | Thrombotic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Arm I (Platinum-based Chemotherapy) | 1 | 187 | |
| other | Thrombotic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Arm II (Olaparib) | 0 | 189 | |
| other | Thrombotic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Arm III (Olaparib, Cediranib Maleate) | 0 | 189 | |
| other | Thrombotic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Japanese Cohort | 0 | 13 | |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Arm I (Platinum-based Chemotherapy) | 0 | 187 | |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Arm II (Olaparib) | 1 | 189 | |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Arm III (Olaparib, Cediranib Maleate) | 0 | 189 | |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Japanese Cohort | 0 | 13 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm I (Platinum-based Chemotherapy) | 0 | 187 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm II (Olaparib) | 1 | 189 |
1 to 10 of 1,664Source ClinicalTrials.gov
See all 1,664 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Platinum-based Chemotherapy) | 72 | 187 |
| Total, all-cause mortality | Arm II (Olaparib) | 95 | 189 |
| Total, all-cause mortality | Arm III (Olaparib, Cediranib Maleate) | 84 | 189 |
| Total, all-cause mortality | Japanese Cohort | 4 | 13 |
| Total, other adverse events | Arm I (Platinum-based Chemotherapy) | 169 | 187 |
| Total, other adverse events | Arm II (Olaparib) | 184 | 189 |
| Total, other adverse events | Arm III (Olaparib, Cediranib Maleate) | 184 | 189 |
| Total, other adverse events | Japanese Cohort | 13 | 13 |
| Total, serious adverse events | Arm I (Platinum-based Chemotherapy) | 18 | 187 |
| Total, serious adverse events | Arm II (Olaparib) | 22 | 189 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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.
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