Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
Summary
The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies. Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.
Timeline
- Start
- 2016-05-18
- Primary completion
- 2019-02-13
- Completion
- 2019-02-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | INCB057643 | Small molecule | 8 mg | Oral |
| Subject | INCB057643 | Small molecule | 12 mg | Oral |
| Subject | INCB057643 | Small molecule | 16 mg | Oral |
| Background | Abiraterone acetate | Small molecule | — | — |
| Background | Azacitidine | Other / unclassified | 75 mg | — |
| Background | Gemcitabine | Small molecule | 1000 mg | — |
| Background | Paclitaxel | Small molecule | 80 mg | — |
| Background | Rucaparib | Small molecule | 600 mg | — |
| Background | Ruxolitinib | Small molecule | 20 mg | — |