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Histone Deacetylase Inhibitor

Ribociclib + Belinostat for Breast Cancer (CHARGE Trial)

Phase 1

Recruiting

Led By Theresa Werner, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance Status ≤ 2

Presence of ≥ 1 metastatic sites of disease that can be safely accessed for biopsy and patient willingness to undergo fresh tissue biopsies of up to 3 lesions

Must not have

History of allergy or hypersensitivity to belinostat, ribociclib, or their binders

Concurrent use of herbal supplements, unless approved by the principal investigator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to assess the maximum tolerated dose of two drugs, ribociclib and belinostat, in combination. The trial will start with a dose escalation, followed by an expansion cohort at the identified dose. Dose escalation will be open to patients with triple-negative breast cancer or ovarian cancer. Dose expansion will only be open to patients with triple-negative breast cancer.

Who is the study for?

This trial is for adults with metastatic triple-negative breast cancer or recurrent ovarian cancer. Participants must have good organ function, be able to swallow pills, and not be pregnant. They should agree to use birth control and provide consent. People with certain heart conditions, unresolved diarrhea, active infections, or those who've had recent major treatments are excluded.

What is being tested?

The study tests the combination of two drugs: Ribociclib and Belinostat. It's designed to find the highest dose patients can tolerate without severe side effects. The trial has two parts: first finding the right dose (dose escalation) and then giving that dose to more people (dose expansion).

What are the potential side effects?

Potential side effects include issues from low blood counts like fatigue or infection risk; liver problems; nausea; vomiting; diarrhea; changes in heart rhythm or function; allergic reactions to medication components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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I agree to have up to 3 biopsies on areas where my cancer has spread.

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I am 18 years old or older.

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I can swallow pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to belinostat, ribociclib, or their components.

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I am not using herbal supplements or they are approved by the study lead.

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I haven't had major surgery or cancer treatment in the last 4 weeks.

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I am not taking any strong medication that affects liver enzymes or blood thinners like warfarin.

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I do not have uncontrolled heart rhythm problems, heart failure, or chest pain.

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I do not have serious heart rhythm problems or a long QT syndrome.

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I have ongoing moderate to severe diarrhea.

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My heart's pumping ability is below normal.

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I have used CDK 4/6 or HDAC inhibitors for my cancer.

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I am currently on medication for an infection.

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I am currently taking medication that affects UGT1A1.

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I am not taking medication known to cause heart rhythm problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MTD of ribociclib and belinostat combination

Secondary study objectives

Objective Response Rate (ORR)

Progression Free Survival (PFS)

frequency and characterization of AEs and SAEs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment: all patientsExperimental Treatment2 Interventions

Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ribociclib

2018

Completed Phase 3

~2420

Belinostat

2006

Completed Phase 2

~430