Trial · NCT04315233
Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
NCT04315233, Phase 1, Terminated, University of Utah
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics. Trials, record NCT04315233. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04315233
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
- NCT number
- NCT04315233
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Metastatic Breast Cancer, Recurrent Ovarian Carcinoma
- Interventions
- Ribociclib, Belinostat
- First posted
- 2020-03-19
- Last updated
- 2026-09-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Dose Limiting Toxicity (DLT) | up to 28 days after initiation of study treatment | This outcome measure will report the count of participants who experienced DLTs during the DLT period. The DLT period is defined as the first cycle of treatment (from cycle one day one dosing to cycle two day 1). Patients will be assessed over this period for the occurrence of adverse events, per CTCAE v5.0. Any of the following events occurring within the defined DLT period which are attributable (possibly, probably, or definitely related) to any or all agents in the combination will be classified as a DLT: * Hematologic: * Grade 3 Thrombocytopenia with clinically significant bleeding * Grade 4-5 Thrombocytopenia * Grade ≥ 3 Febrile Neutropenia * Grade 4-5 Neutropenia lasting \>7 days * Non-Hematologic: * Any grade ≥ 4 toxicity * Any grade 3 toxicity lasting \>48 hours despite maximal medical therapy except for clinically non-significant laboratory abnormalities. * Grade ≥ 3 Electrocardiogram (ECG) corrected QT interval by Fredericia (QTcF) prolongation |
| Secondary | Frequency of Attributed Adverse Events (AEs) and Serious Adverse Events (SAEs) | up to 5 months from the start of study treatment | To assess the safety of ribociclib and belinostat in combination. This outcome measure will report the count of participants who experienced an Grade 3 or higher Adverse Event (AE) or Serious Adverse Event (SAE) related to ribociclib and belinostat. Events with a Definite, Probable, or Possible attribution were considered attributed to ribociclib and belinostatin. |
| Secondary | Progression Free Survival (PFS) | up to 4 months | To assess the efficacy in the study population. Progression-free survival (PFS) is defined as the time from study drug initiation to the time of documented disease progression (as assessed by RECIST 1.1) or death from any cause. |
| Secondary | Objective Response Rate (ORR) | up to 4 months | To assess the efficacy in the study population. Objective response rate is defined as the proportion of patients achieving CR (Complete Response) or PR (Partial Response), as assessed by RECIST 1.1 while on study treatment. CR was defined as a the disappearance of all target lesions and non-target lesions. PR was defined as a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD, for a minimum of four weeks. |
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.
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 |
|---|---|---|---|---|---|
| U54CA209978 | Combating Subclonal Evolution of Resistant Cancer Phenotypes | BILD, ANDREA HOPE | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 2017 to 2021 |
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.
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/NCT04315233
GET https://conductscience.org/api/trials/v1/NCT04315233/registered