Trial · NCT04703920
Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer
NCT04703920, Phase 1, Completed, University of Michigan Rogel Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer. Trials, record NCT04703920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04703920
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer
- NCT number
- NCT04703920
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Conditions
- Metastatic Breast Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Ovarian Carcinoma, Metastic or Unresectable Pancreatic Adenocarcinoma
- Interventions
- Talazoparib, Belinostat
- First posted
- 2021-01-11
- Last updated
- 2025-01-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limiting toxicities (DLT) within the first two cycles of treatment | 10 weeks | Number of DLT's experienced by participants within the first two cycles. A DLT will be defined as any treatment related toxicity of grade 3 or 4 unless otherwise defined in the protocol. DLTs will be assessed via the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Secondary | Proportion of patients experiencing toxicities. Participants may continue to receive the investigational study therapy until disease progression or unacceptable toxicity. | Up to 30 days post last treatment, up to approximately 6 months | The proportion of patients experiencing toxicities will be reported by dose level and grade. Toxicities and grading per the NCI CTCAE version 5.0. |
| Secondary | Plasma concentrations of talazoparib at steady state | Day 5 of cycle 1; up to day 5 of cycle 3 | Plasma concentrations of talazoparib at steady state will be measured to evaluate its pharmacokinetic (PK) profile, with combination therapy of talazoparib and belinostat. Sparse PK assessment will occur at multiple time points from day 5 of cycle 1 through day 5 of cycle 3 in order to assess steady-state trough levels. The plasma concentrations will be determined by liquid chromatography, high-resolution mass spectrometry, and summarized descriptively by dose level. |
| Secondary | Plasma concentrations of belinostat at steady state | Day 5 of cycle 1; up to day 5 of cycle 3 | Plasma concentrations of belinostat at steady state will be measured to evaluate its PK profile, with combination of talazoparib and belinostat. Sparse PK assessment will occur at multiple time points from day 5 of cycle 1 through day 5 of cycle 3 in order to assess steady-state trough levels. The plasma concentrations will be determined by liquid chromatography, high-resolution mass spectrometry, and summarized descriptively by dose level. |
| Secondary | Number of patients with an objective response | Up to 30 days post last treatment, up to approximately 6 months | Number of patients with an objective response per the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 will be reported by dose level. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT04703920
GET https://conductscience.org/api/trials/v1/NCT04703920/registered