drugset / Trial / NCT03217669
Epacadostat (INCB24360) in Combination With Sirolimus in Advanced Malignancy
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a small phase I study with dose escalation and dose expansion cohorts. The former cohort will need up to 12 subjects with advanced solid tumor to define feasibility and recommended phase 2 dose (RP2D); the latter up to 10 subjects to further define safety. Study subjects will be adults with advanced solid tumor (dose escalation) and advanced non-small cell lung cancer (NSCLC) who progressed on at least one first-line systemic therapy (dose expansion).
Timeline
- Start
- 2018-02-22
- Primary completion
- 2024-04-01
- Completion
- 2025-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epacadostat | Small molecule | 100 mg | Oral |
| Subject | Epacadostat | Small molecule | 300 mg | Oral |
| Subject | Sirolimus | Small molecule | 1 mg | Oral |
| Subject | Sirolimus | Small molecule | 2 mg | Oral |
| Subject | Sirolimus | Small molecule | 3 mg | Oral |
| Subject | Sirolimus | Small molecule | 6 mg | Oral |