MedTrace Logo

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

NCT02711137 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2025-10-21

Study results available
· View outcomes & findings →

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Fred Zheng, MD, PhD · Incyte Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-18
Primary Completion
2019-02-13
Completion
2019-02-13
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02711137 on ClinicalTrials.gov