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NCT04315233 · ClinicalTrials.gov registry record · Phase 1
Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
A Phase 1 study of Metastatic Breast Cancer and Recurrent Ovarian Carcinoma, sponsored by University of Utah.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 2
- Study locations
NCT04315233: Recruiting Phase 1 study of Metastatic Breast Cancer and Recurrent Ovarian Carcinoma, sponsored by University of Utah.
NCT04315233 is a Phase 1 study of Metastatic Breast Cancer and Recurrent Ovarian Carcinoma that is actively recruiting participants, run by University of Utah. The registered enrollment target is 34 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04315233, a Phase 1 study of Metastatic Breast Cancer and Recurrent Ovarian Carcinoma, is actively recruiting participants, sponsored by University of Utah.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is an open-label, multi-center, phase I study designed to assess the maximum tolerated dose of ribociclib and belinostat in combination. The trial will open with a dose escalation followed by an expansion cohort at the identified dose. Dose escalation will be open to the enrollment of patients diagnosed with triple-negative breast cancer or ovarian cancer. Dose expansion will only be open to patients diagnosed with triple-negative breast cancer.
Primary Outcome
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 classi
Conditions Studied
Interventions
- DRUG Ribociclib
- DRUG Belinostat
Study Locations (2)
Utah
- Huntsman Cancer Institute - Salt Lake City
Virginia
- Inova Schar Cancer Institute - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
What NCT04315233 shows while recruiting
NCT04315233 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Ribociclib is the first listed.
NCT04315233 reports a single indexed study location in Utah, Virginia.
Frequently Asked Questions
What is clinical trial NCT04315233 about?
NCT04315233 is a clinical study titled "Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics". This is an open-label, multi-center, phase I study designed to assess the maximum tolerated dose of ribociclib and belinostat in combination. The trial will open with a dose escalation followed by an expansion cohort at the identified dose. Dose escalation will be open to the enrollment of patients ...
What is the current status of trial NCT04315233?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2021-05-03. Estimated completion is 2026-08.
What conditions does trial NCT04315233 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Recurrent Ovarian Carcinoma.
What interventions are being tested in trial NCT04315233?
The interventions under investigation include: Ribociclib (DRUG), Belinostat (DRUG).
Who is sponsoring clinical trial NCT04315233?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04315233 being conducted?
This trial has 2 study locations across Utah, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04315233's enrollment target sits among peer trials
34 100th of 139 higher than 39 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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