NCT02711137

Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	INCB057643	Initial cohort dose of INCB057643 at the protocol-specified starting dose (Part 1), with subsequent dose escalations based on protocol-specific criteria. The recommended treatment group-specific dose(s) will be taken forward into expansion cohorts (Part 2).
DRUG	Gemcitabine	Standard of Care (SOC) agents
DRUG	Paclitaxel	Standard of Care (SOC) agents
DRUG	Rucaparib	Standard of Care (SOC) agents
DRUG	Abiraterone	Standard of Care (SOC) agents
DRUG	Ruxolitinib	Standard of Care (SOC) agents
DRUG	Azacitidine	Standard of Care (SOC) agents

Timeline

• Start date: 2016-05-18
• Primary completion: 2019-02-13
• Completion: 2019-02-13
• First posted: 2016-03-17
• Last updated: 2025-10-21
• Results posted: 2022-04-28

Locations

18 sites across 3 countries: United States, Belgium, France

Regulatory

• FDA-regulated drug study