Actively Recruiting
Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
Led by University of Utah · Updated on 2025-04-22
34
Participants Needed
2
Research Sites
273 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For dose escalation: Pathologically confirmed breast cancer with measurable disease, ER and PR ≤ 1%, Her-2/neu negative, metastatic or unresectable and locally advanced not suitable for curative treatment
- Or pathologically confirmed recurrent, unresectable serous ovarian cancer
- For dose expansion: Pathologically confirmed breast cancer with measurable disease, ER and PR ≤ 1%, Her-2/neu negative, metastatic or unresectable and locally advanced not suitable for curative treatment
- Age 18 or older
- ECOG performance status 0, 1, or 2
- Able to swallow pills
- Adequate organ function with specified blood count and liver, kidney tests
- At least one metastatic site accessible for biopsy and willing to undergo up to 3 biopsies
- Negative pregnancy test for women of childbearing potential
- Agreement to use approved birth control during and for 6 months after treatment
- Able to provide informed consent
You will not qualify if you...
- Previous treatment with CDK4/6 or HDAC inhibitors
- Major surgery, radiotherapy, anticancer therapy, or investigational agents within 4 weeks or 5 half-lives before treatment
- Active or progressive brain metastases or leptomeningeal disease unless stable
- Medical conditions requiring valproic acid use near treatment
- Active infection requiring systemic therapy
- Allergy or hypersensitivity to study drugs or their components
- Uncontrolled heart conditions including arrhythmia, heart failure, recent myocardial infarction, or significant cardiac abnormalities
- Baseline QTcF >450 msec or heart rate outside 50-90 BPM on ECG
- Concurrent use of certain medications or herbal supplements affecting drug metabolism
- Unresolved diarrhea grade 2 or higher
- Use of strong/moderate CYP3A4/5 inducers or inhibitors, or drugs with narrow therapeutic windows within 7 days before treatment
- Current use of warfarin or coumarin anticoagulants
- Impaired gastrointestinal function affecting medication absorption
- Pregnant or breastfeeding
- Women and men not using highly effective contraception during and for 6 months after treatment
- Known HIV with detectable viral load or chronic hepatitis B or C with detectable viral load
- Other malignancies needing systemic treatment within 1 year
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
2
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
J
Janna Espinosa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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