Trial · NCT01116648
Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer
NCT01116648, Phase 1, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2020-07-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer. Trials, record NCT01116648. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01116648
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer
- NCT number
- NCT01116648
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 155 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Fallopian Tube Carcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Ovarian Serous Adenocarcinoma, Ovarian Serous Surface Papillary Adenocarcinoma, Primary Peritoneal Serous Adenocarcinoma, Triple-Negative Breast Carcinoma
- Interventions
- Biopsy Procedure, Biospecimen Collection, Cediranib Maleate, Computed Tomography, Echocardiography Test, Magnetic Resonance Imaging, Multigated Acquisition Scan, Olaparib
- First posted
- 2010-05-05
- Last updated
- 2026-07-14
- Results first posted
- 2020-07-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) | At 28 days | Was determined using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 |
| Primary | The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I) | At 28 Days | This trial employed a 3+3 design, escalating on 0/3 or 1/6 DLT, and de-escalating if 2 DLTs were encountered. The MTD (maximum tolerated dose) was the dose at which no more than 1 patient developed a dose-limiting toxicity (DLT) when at least 6 patients had been treated. |
| Primary | Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II) | Time from start of treatment to time of objective disease progression, assessed up to 5 years | Evaluated by Kaplan-Meier analysis and log-rank test for between group comparison, and median survival times reported. PFS is defined as time from randomization to investigator-assessed radiographic progression by RECIST 1.1 criteria or death. Patients alive without evidence of progression were censored at the last disease assessment. |
| Primary | The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). | At 28 days | The Phase 1-T component of this trial employed a 3+3 design, escalating on 0/3 or 1/6 DLT, and de-escalating if 2 DLTs were encountered. The MTD (maximum tolerated dose) was the dose at which no more than 1 patient developed a DLT when at least 6 patients had been treated. |
| Secondary | Number of Participants With Treatment-related Toxicities of the Combination of Cediranib Maleate and Olaparib (Phase I) | Adverse Events monitored for 3 years, mortality assessed up to 5 years | Will be determined using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, study-related adverse events observed in \>10% of participants (n=28). |
| Secondary | Tumor Response Rate (Objective Response Rate) Defined by Response Evaluation Criteria in Solid Tumors Criteria (Phase II) | Up to 5 years | The response rates are compared by an exact test and 95% confidence intervals will also be reported. Objective response rate (ORR) is defined as the best confirmed RECIST response, ORR is defined as the number of participants with CR, PR or SD. |
| Secondary | Overall Survival (Phase II) | Up to 5 years | Will be evaluated by Kaplan-Meier analysis and log-rank test for between-group comparison, and median survival time will be reported. |
| Secondary | Number of Participants With Treatment-related Toxicities of the Combination of Cediranib and Olaparib (Tablet Formulation) in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). | Up to 3 years | Will be determined using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. This outcome reports treatment-related adverse events that occurred in at least 10% of participants. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) | At 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I) | At 28 Days | mg | NUMBER | |
| PRIMARY | Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II) | Time from start of treatment to time of objective disease progression, assessed up to 5 years | Platinum-sensitive recurrent grade 2 or 3 platinum-sensitive papillary-serous or endometrioid ovarian, fallopian tube, or peritoneal cancer. | months | MEDIAN |
| PRIMARY | The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). | At 28 days | mg | NUMBER | |
| SECONDARY | Number of Participants With Treatment-related Toxicities of the Combination of Cediranib Maleate and Olaparib (Phase I) | Adverse Events monitored for 3 years, mortality assessed up to 5 years | |||
| SECONDARY | Tumor Response Rate (Objective Response Rate) Defined by Response Evaluation Criteria in Solid Tumors Criteria (Phase II) | Up to 5 years | |||
| SECONDARY | Overall Survival (Phase II) | Up to 5 years | |||
| SECONDARY | Number of Participants With Treatment-related Toxicities of the Combination of Cediranib and Olaparib (Tablet Formulation) in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). | Up to 3 years |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) | Level 0 | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) | Level 1 | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) | Level 2 | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) | Level 3 | 2 | Participants | ||
The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I) | All Phase 1 Participants (28 Participants) | Cediranib PO daily | 30 | mg | |
The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I) | All Phase 1 Participants (28 Participants) | Olaparib PO BID | 200 | mg | |
| Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II) | Phase 2 - Olaparib Alone (46 Participants) | 8.2 | Full Range 1 to 49 | months | |
| Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II) | Phase 2 - Cediranib/Olaparib (44 Participants) | 16.5 | Full Range 4 to 60 | months | |
| The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). | All Phase 1-T Participants | Cediranib PO daily | 30 | mg | |
| The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). | All Phase 1-T Participants | Olaparib (tablet) PO BID | 200 | mg |
Source ClinicalTrials.gov
Participant flow630
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 Dose Level 0 | STARTED | Dose Level 0 (20mg Ced+100mg Olap) | 3 | |
| Phase 1 Dose Level 0 | STARTED | Dose Level 1 (20mg Ced + 200mg Olap) | 0 | |
| Phase 1 Dose Level 0 | STARTED | Dose Level 2 (30mg Ced + 200mg Olap) | 0 | |
| Phase 1 Dose Level 0 | STARTED | Dose Level 3 (30mg Ced + 400mg Olap) | 0 | |
| Phase 1 Dose Level 0 | STARTED | Expansion Cohort at MTD | 0 | |
| Phase 1 Dose Level 0 | STARTED | Phase 2 - Olaparib Alone | 0 | |
| Phase 1 Dose Level 0 | STARTED | Phase 2 - Cediranib/Olaparib | 0 | |
| Phase 1 Dose Level 0 | STARTED | Phase 1-T Dose Level 0-TA | 0 | |
| Phase 1 Dose Level 0 | STARTED | Phase 1-T Dose Level 1-TA | 0 | |
| Phase 1 Dose Level 0 | STARTED | Phase 1-T Dose Level 2-TA | 0 |
1 to 10 of 630Source ClinicalTrials.gov
See all 630 participant flowAdverse events2,940
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 | Abdominal distension | Gastrointestinal disorders | Phase I Dose Level 0 | 0 | 3 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase I Dose Level 1 | 0 | 3 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase I Dose Level 2 | 0 | 7 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase I Dose Level 3 | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase I Expansion Cohort at MTD | 1 | 9 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase II Olaparib Alone | 0 | 46 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase II Cediranib/Olaparib | 0 | 44 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase I-T Dose Level 0-TA | 0 | 3 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase I-T Dose Level 1-TA | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase I-T Dose Level 1-TPKCed | 1 | 7 |
1 to 10 of 2,940Source ClinicalTrials.gov
See all 2,940 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I Dose Level 0 | 3 | 3 |
| Total, all-cause mortality | Phase I Dose Level 1 | 3 | 3 |
| Total, all-cause mortality | Phase I Dose Level 2 | 6 | 7 |
| Total, all-cause mortality | Phase I Dose Level 3 | 6 | 6 |
| Total, all-cause mortality | Phase I Expansion Cohort at MTD | 7 | 9 |
| Total, all-cause mortality | Phase II Olaparib Alone | 29 | 46 |
| Total, all-cause mortality | Phase II Cediranib/Olaparib | 26 | 44 |
| Total, all-cause mortality | Phase I-T Dose Level 0-TA | 1 | 3 |
| Total, all-cause mortality | Phase I-T Dose Level 1-TA | 2 | 6 |
| Total, all-cause mortality | Phase I-T Dose Level 1-TPKCed | 2 | 7 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants3
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 | Source |
|---|---|---|---|---|---|---|
| P30CA006516 | Dana-Farber/Harvard Cancer Center | EBERT, BENJAMIN LEVINE | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| UM1CA186709 | Dana-Farber/Harvard Cancer Center Experimental Therapeutics Clinical Trials Network Site (DF/HCC ETCTN Site) | SHAPIRO, GEOFFREY I.; FLAHERTY, KEITH T; KUFE, DONALD W. | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| U01CA062490 | Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis | KUFE, DONALD W. | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 1994 to 2013 | 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/NCT01116648
GET https://conductscience.org/api/trials/v1/NCT01116648/flow?page=2