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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 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.

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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.

Interventions

  • DRUG Ribociclib
  • DRUG Belinostat

Study Locations (2)

Utah

  • Huntsman Cancer Institute - Salt Lake City

Virginia

  • Inova Schar Cancer Institute - Fairfax

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2021-05-03
Est. Completion 2026-08
Phase Phase 1

Sponsor

University of Utah

818 total trials

What the Registry Record Tells You About NCT04315233

The ClinicalTrials.gov registry entry for NCT04315233 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (83% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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