Trial · NCT02898207
Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer
NCT02898207, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2023-04-26
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer. Trials, record NCT02898207. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02898207
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer
- NCT number
- NCT02898207
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 28 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Metastatic High Grade Fallopian Tube Serous Adenocarcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Primary Peritoneal Serous Adenocarcinoma, Metastatic Triple-Negative Breast Carcinoma, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Recurrent Breast Carcinoma, Recurrent High Grade Fallopian Tube Serous Adenocarcinoma, Recurrent High Grade Ovarian Serous Adenocarcinoma, Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma, Recurrent Triple-Negative Breast Carcinoma, Refractory Fallopian Tube Serous Adenocarcinoma, Refractory Ovarian Serous Adenocarcinoma, Refractory Primary Peritoneal Serous Adenocarcinoma, Refractory Triple-Negative Breast Carcinoma, Unresectable High Grade Fallopian Tube Serous Adenocarcinoma, Unresectable Malignant Solid Neoplasm, Unresectable Primary Peritoneal Serous Adenocarcinoma
- Interventions
- Olaparib, Onalespib
- First posted
- 2016-09-13
- Last updated
- 2023-04-26
- Results first posted
- 2023-04-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Olaparib Administered in Combination With Onalespib | Up to 35 days for each dose level cohort | MTD was determined by testing increasing doses of the combination of olaparib PO and onalespib IV within dose escalation cohorts consisting of 3 to 6 evaluable participants. MTD reflects the highest dose combination that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants. DLTs were defined based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Enrollment to this study was suspended prior to completion of the dose escalation due to discontinuation of further development of onalespib. A true single MTD therefore could not be determined. The two dose levels included in this outcome measure represent the highest well-tolerated dose combinations (Dose Level 2 \[DL2\]: Olaparib 300 mg PO BID and Onalespib 40 mg/m\^2 IV; and Dose Level 2a \[DL2a\]: Olaparib 200 mg PO BID and Onalespib 80 mg/m\^2 IV). |
| Primary | Maximum Tolerated Dose (MTD) of Onalespib Administered in Combination With Olaparib | Up to 35 days for each dose level cohort | MTD was determined by testing increasing doses of the combination of olaparib PO and onalespib IV within dose escalation cohorts consisting of 3 to 6 evaluable participants. MTD reflects the highest dose combination that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants. DLTs were defined based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. |
| Secondary | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Within Cycles 0 and 1 (up to 35 days). | DLTs were based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 and were defined as any grade 3 or 4 non-hematologic toxicity (excluding grade 3: fatigue; diarrhea, constipation, and nausea and/or vomiting controlled with supportive measured within 24 hours; hypophosphatemia; hyponatremia; hypomagnesemia; and rash that resolves to \< grade 3 within \< 5 days), grade 4 neutropenia of \> 7 day duration, febrile neutropenia, grade 4 thrombocytopenia or bleeding associated with grade 3 thrombocytopenia, requirement for repeated blood transfusion within 4-6 weeks, any other grade 4 hematologic toxicity, any study treatment-related death, any grade 3 or 4 event considered to be dose-limiting in the opinion of the investigator, and the inability to take 75% or more of the planned dose for olaparib and 4 out of 6 doses for onalespib within the DLT period due to treatment-related adverse events. |
| Secondary | Number of Participants Who Experienced Treatment-Related Toxicities | Up to 67 weeks | Treatment-related toxicities in this outcome include non-hematologic and hematologic adverse events that were either Grade 3+ or occurred in at least 10% of all treated participants, and were considered at least possibly related to olaparib and/or onalespib. Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. |
| Secondary | Number of Participants With Objective Responses by RECIST 1.1 | Up to 63 weeks | Responses determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI, where Objective Response (OR) represents either a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum diameters). |
| Secondary | Number of Participants Progression-Free for At Least 24 Weeks by RECIST 1.1 | Up to 24 weeks | Responses determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI, where Progressive Disease (PD) represents (relative to baseline) at least a 20% increase in the sum of diameters of target lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. The duration of progression-free status was defined as the interval from the date of enrollment to date of either PD or date of last disease assessment. |
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 | Maximum Tolerated Dose (MTD) of Olaparib Administered in Combination With Onalespib | Up to 35 days for each dose level cohort | Seven of the 28 patients were not evaluable for DLT assessment and were replaced. | mg | NUMBER |
| PRIMARY | Maximum Tolerated Dose (MTD) of Onalespib Administered in Combination With Olaparib | Up to 35 days for each dose level cohort | Seven of the 28 patients were not evaluable for DLT assessment and were replaced. | mg/m2 | NUMBER |
| SECONDARY | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Within Cycles 0 and 1 (up to 35 days). | Patients were considered not evaluable for the DLT outcome if they did not receive at least 75% of the planned olaparib doses or at least 4 doses of onalespib for reasons other than toxicity or DLT. Dose Level 3a did not complete evaluation as enrollment was suspended due to discontinuation of further development of onalespib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced Treatment-Related Toxicities | Up to 67 weeks | One patient was enrolled under Dose Level 3, but was erroneously treated at Dose Level 2. This patient was replaced within the dose escalation, but remained on treatment on Dose Level 2 throughout the remainder of trial participation. For the purposes of adverse event reporting, this patient has been included in Dose Level 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Objective Responses by RECIST 1.1 | Up to 63 weeks | Only participants who had their disease re-evaluated via CT or MRI were considered evaluable for response. Six of the 28 participants were taken off study therapy prior to their first on-study disease evaluation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Progression-Free for At Least 24 Weeks by RECIST 1.1 | Up to 24 weeks | Only participants who had their disease re-evaluated via CT or MRI were considered evaluable for response. Six of the 28 participants were taken off study therapy prior to their first on-study disease evaluation. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group142
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Olaparib Administered in Combination With Onalespib | All Evaluable Participants | Dose Level 2 Olaparib PO BID | 300 | mg | |
| Maximum Tolerated Dose (MTD) of Olaparib Administered in Combination With Onalespib | All Evaluable Participants | Dose Level 2a Olaparib PO BID | 200 | mg | |
| Maximum Tolerated Dose (MTD) of Onalespib Administered in Combination With Olaparib | All Evaluable Participants | Dose Level 2 Onalespib IV on Days 1, 2, 8, 9, 15, and 16 | 40 | mg/m2 | |
| Maximum Tolerated Dose (MTD) of Onalespib Administered in Combination With Olaparib | All Evaluable Participants | Dose Level 2a Onalespib IV on Days 1, 2, 8, 9, 15, and 16 | 80 | mg/m2 | |
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Dose Level 0: Olaparib 200 mg and Onalespib 20 mg/m^2 | 0 | Participants | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Dose Level 1: Olaparib 200 mg and Onalespib 40 mg/m^2 | 0 | Participants | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Dose Level 2: Olaparib 300 mg and Onalespib 40 mg/m^2 | 0 | Participants | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Dose Level 3: Olaparib 300 mg and Onalespib 80 mg/m^ | 0 | Participants | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Dose Level 2a: Olaparib 200 mg and Onalespib 80 mg/m^2 | 2 | Participants | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Dose Level 3a: Olaparib 200 mg and Onalespib 120 mg/m^2 | 1 | Participants |
1 to 10 of 142Source ClinicalTrials.gov
See all 142 results by groupParticipant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Level 0 | STARTED | Dose Level 0: Olaparib 200 mg and Onalespib 20 mg/m^2 | 3 | |
| Dose Level 0 | STARTED | Dose Level 1: Olaparib 200 mg and Onalespib 40 mg/m^2 | 0 | |
| Dose Level 0 | STARTED | Dose Level 2: Olaparib 300 mg and Onalespib 40 mg/m^2 | 0 | |
| Dose Level 0 | STARTED | Dose Level 3: Olaparib 300 mg and Onalespib 80 mg/m^2 | 0 | |
| Dose Level 0 | STARTED | Dose Level 2a: Olaparib 200 mg and Onalespib 80 mg/m^2 | 0 | |
| Dose Level 0 | STARTED | Dose Level 3a: Olaparib 200 mg and Onalespib 120 mg/m^2 | 0 | |
| Dose Level 0 | COMPLETED | Dose Level 0: Olaparib 200 mg and Onalespib 20 mg/m^2 | 3 | |
| Dose Level 0 | COMPLETED | Dose Level 1: Olaparib 200 mg and Onalespib 40 mg/m^2 | 0 | |
| Dose Level 0 | COMPLETED | Dose Level 2: Olaparib 300 mg and Onalespib 40 mg/m^2 | 0 | |
| Dose Level 0 | COMPLETED | Dose Level 3: Olaparib 300 mg and Onalespib 80 mg/m^2 | 0 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events768
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 | Diarrhea | Gastrointestinal disorders | Dose Level 0 | 3 | 3 | |
| other | Diarrhea | Gastrointestinal disorders | Dose Level 1 | 3 | 4 | |
| other | Diarrhea | Gastrointestinal disorders | Dose Level 2 | 4 | 7 | |
| other | Diarrhea | Gastrointestinal disorders | Dose Level 3 | 4 | 6 | |
| other | Diarrhea | Gastrointestinal disorders | Dose Level 2a | 3 | 3 | |
| other | Diarrhea | Gastrointestinal disorders | Dose Level 3a | 5 | 5 | |
| other | Nausea | Gastrointestinal disorders | Dose Level 0 | 2 | 3 | |
| other | Nausea | Gastrointestinal disorders | Dose Level 1 | 3 | 4 | |
| other | Nausea | Gastrointestinal disorders | Dose Level 2 | 6 | 7 | |
| other | Nausea | Gastrointestinal disorders | Dose Level 3 | 6 | 6 |
1 to 10 of 768Source ClinicalTrials.gov
See all 768 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 0 | 0 | 3 |
| Total, all-cause mortality | Dose Level 1 | 0 | 4 |
| Total, all-cause mortality | Dose Level 2 | 0 | 7 |
| Total, all-cause mortality | Dose Level 3 | 1 | 6 |
| Total, all-cause mortality | Dose Level 2a | 0 | 3 |
| Total, all-cause mortality | Dose Level 3a | 0 | 5 |
| Total, other adverse events | Dose Level 0 | 3 | 3 |
| Total, other adverse events | Dose Level 1 | 4 | 4 |
| Total, other adverse events | Dose Level 2 | 7 | 7 |
| Total, other adverse events | Dose Level 3 | 6 | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| 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 |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT02898207
GET https://conductscience.org/api/trials/v1/NCT02898207/results?page=2