RecruitingPhase 1NCT04315233

Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE)


Sponsor

University of Utah

Enrollment

34 participants

Start Date

May 3, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — ribociclib (a targeted drug that blocks cancer cell division) and belinostat (a drug that changes how cancer cells read their DNA) — in patients with metastatic triple-negative breast cancer or recurrent ovarian cancer, guided by genomic (genetic) testing. **You may be eligible if...** - You have metastatic triple-negative breast cancer (hormone receptor-negative, HER2-negative) that has not responded to prior treatment - Or you have recurrent serous ovarian cancer that cannot be surgically removed - You have measurable disease on imaging (per RECIST 1.1 criteria) - Your organ function meets minimum requirements **You may NOT be eligible if...** - You have hormone receptor-positive or HER2-positive breast cancer - Your cancer has spread to the brain with active symptoms - You have serious heart rhythm problems - You are pregnant or breastfeeding - You have had certain prior treatments that would exclude you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRibociclib

Ribociclib Dose Level 0 (starting dose) 200mg QD Dose Level 1A 400mg QD on Days 8-28 Dose Level 1B 200mg QD Dose Level 2 400mg QD on Days 8-28

DRUGBelinostat

Belinostat Dose Level 0 (starting dose) 600mg/m2 daily for 5 days Dose Level 1A 600mg/m2 daily for 5 days Dose Level 1B 1000mg/m2 daily for 5 days Dose Level 2 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules.


Locations(2)

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

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NCT04315233


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