drugset / Trial / NCT04315233
Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-05-03
- Primary completion
- 2025-06
- Completion
- 2026-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belinostat | Small molecule | 600 mg/m2 | — |
| Subject | Belinostat | Small molecule | 1000 mg/m2 | — |
| Subject | Ribociclib | Small molecule | 200 mg | — |
| Subject | Ribociclib | Small molecule | 400 mg | — |