Trial · NCT02474173
Onalespib and Paclitaxel in Treating Patients With Advanced Triple Negative Breast Cancer
NCT02474173, Phase 1, Terminated, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Onalespib and Paclitaxel in Treating Patients With Advanced Triple Negative Breast Cancer. Trials, record NCT02474173. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02474173
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Onalespib and Paclitaxel in Treating Patients With Advanced Triple Negative Breast Cancer
- NCT number
- NCT02474173
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 31 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7, Triple-Negative Breast Carcinoma
- Interventions
- Laboratory Biomarker Analysis, Onalespib, Paclitaxel, Pharmacological Study
- First posted
- 2015-06-17
- Last updated
- 2022-11-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase 2 dose (R2PD) | Up to 28 days | Defined as level at which no more than 1 of 6 patients experience a dose limiting toxicity (maximum tolerated dose or \[MTD\]); or doses of the combination below MTD, if in the opinion of the investigators, lower doses are better tolerated and safer. |
| Primary | Toxicity profile of onalespib in combination with paclitaxel | Up to 2 years | Will be based on the Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5.0. |
| Secondary | Pharmacokinetic (PK) parameters of onalespib | Pre-dose, immediately prior to end of infusion, 0.5, 1, 2, 4, 6, 8, and 24 hours after end of infusion on day -7 of course 1 and day 8 (and prior to starting paclitaxel, and immediately prior to end of infusion of paclitaxel on day 8) | A descriptive analysis will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit). |
| Secondary | Pharmacokinetic (PK) parameters of paclitaxel | Pre-dose, immediately prior to end of infusion, 0.5, 1, 2, 4, 6, 8, and 24 hours after end of infusion on days 1 and 8 of course 1 (and immediately prior to end of infusion of onalespib, prior to starting paclitaxel on day 8) | A descriptive analysis will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit). |
| Secondary | Overall response rate (partial response [PR]+ complete response [CR]) | Up to 6 months | Will be assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Overall response will be assessed in all patients in an exploratory manner, using summary statistics, by dose level. Will also calculate corresponding 95% binomial confidence intervals for these response rates. |
| Secondary | Response duration | From the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years | Will be based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. |
| Secondary | Progression-free survival | From study enrollment to first documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause (whichever occurs first), assessed up to 2 years | Progression free survival will be summarized using Kaplan and Meier methods, where patients who are event-free at the time of their last evaluation will be censored at that time point. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38152697 | 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 |
|---|---|---|---|---|---|
| UM1CA186712 | The Ohio State University as a Lead Academic Organization (LAO) for the Experimental Therapeutics Clinical Trials Network | CARSON, WILLIAM E.; ARNOLD, SUSANNE M; EPPERLA, NARENDRANATH | OHIO STATE UNIVERSITY | 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/NCT02474173
GET https://conductscience.org/api/trials/v1/NCT02474173/registered