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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT04315233
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    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
  • Belinostat — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 3, 2021
Status verified
Apr 2025
Primary completion
Jun 30, 2025
Completion
Aug 31, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Dose Escalation Cohort
    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.
  • Experimental: Cohort 2: Dose expansion cohort
    Participant will be enrolled in dose expansion cohort at the identified Recommended Phase 2 Dose (RP2D). Dose escalation will be open to the enrollment of patients diagnosed with triple-negative breast cancer or ovarian cancer. However, dose expansion will only be open to the enrollment of patients diagnosed with triple-negative breast cancer

Primary Outcome Measure

MTD of ribociclib and belinostat combination [ Time Frame: C1D1 to C2D1 (each cycle is 28 days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Huntsman Cancer InstituteSalt Lake CityUtah84112
Janna Espinosa
[email protected]
801-585-0571
Inova Schar Cancer InstituteFairfaxVirginia22031
Stephanie L Van Bebber
[email protected]
571-472-0213
Adam Cohen (PRINCIPAL_INVESTIGATOR)

Find similar trials in Salt Lake City, UT

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Huntsman Cancer Institute· Salt Lake City, UTInova Schar Cancer Institute· Fairfax, VA

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