Ribociclib + Belinostat for Breast Cancer
(CHARGE Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires stopping certain medications, including those that inhibit UGT1A1, herbal supplements, and medications with a risk of inducing Torsades de Pointes, at least 7 days before starting the study. You should discuss your current medications with the trial team to see if any need to be stopped or adjusted.
What data supports the effectiveness of the drug Ribociclib in combination with Belinostat for breast cancer?
Ribociclib, when used with other drugs like letrozole, has shown to improve progression-free survival (the time during and after treatment that a patient lives with the disease without it getting worse) in patients with hormone receptor-positive, HER2-negative advanced breast cancer. This suggests that Ribociclib can be effective in treating certain types of breast cancer.12345
Is the combination of Ribociclib and Belinostat safe for humans?
Ribociclib has been studied in combination with other drugs for breast cancer and is generally considered safe, but it can cause side effects like low white blood cell counts, nausea, and fatigue. It may also affect liver function and heart rhythm, so patients with heart issues should be cautious. There is no specific safety data available for the combination of Ribociclib and Belinostat.13467
How is the drug combination of Ribociclib and Belinostat unique for breast cancer treatment?
The combination of Ribociclib and Belinostat is unique because Ribociclib is a CDK 4/6 inhibitor that has shown improved survival in hormone receptor-positive, HER2-negative breast cancer, while Belinostat is a histone deacetylase inhibitor, potentially offering a novel mechanism of action by targeting different pathways in cancer cells.13489
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Ribociclib and belinostat are given at escalating doses to determine the maximum tolerated dose (MTD)
Dose Expansion
Participants receive the identified MTD of ribociclib and belinostat to further assess safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Belinostat (Histone Deacetylase Inhibitor)
- Ribociclib (CDK4/6 Inhibitor)
Belinostat is already approved in United States for the following indications:
- Peripheral T-cell lymphoma (PTCL)