A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

149

Participants

Timeline

Start Date

November 21, 2017

Primary Completion Date

November 28, 2022

Study Completion Date

November 28, 2022

Conditions
Biliary Tract Cancer (BTC)Colorectal Cancer (CRC)Endometrial CancerGastroesophageal Cancer (GC)Ovarian CancerSolid Tumors
Interventions
DRUG

INCB001158

Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.

DRUG

Oxaliplatin

Oxaliplatin administered intravenously at the protocol-defined dose and schedule.

DRUG

Leucovorin

Leucovorin at the protocol-defined dose and regimen.

DRUG

5-Fluorouracil

5-Fluorouracil at the protocol-defined dose and regimen.

DRUG

Gemcitabine

Gemcitabine at the protocol-defined dose and regimen.

DRUG

Cisplatin

Cisplatin at the protocol-defined dose and regimen.

DRUG

Paclitaxel

Paclitaxel at the protocol-defined dose and regimen.

Trial Locations (10)

6000

Grand Hopital de Charleroi - Department of Medical Oncology, Brussels

30060

Northwest Georgia Oncology Centers, Marietta

36604

USA Mitchell Cancer Center, Mobile

77030

The University of Texas MD Anderson Cancer Center, Houston

78229

START San Antonio, San Antonio

95817

UC Davis - Comprehensive Cancer Centre, Sacramento

35294-3300

University of Alabama, Birmingham

B-1000

Institut Jules Bordet - Clinical Trials Conduct Unit, Brussels

WC1E 6BT

UCL Cancer Institute, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY