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

NCT03314935 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2025-08-12

Study results available
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Summary

The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Lance Leopold, MD · 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
2017-11-21
Primary Completion
2022-11-28
Completion
2022-11-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • United Kingdom

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 NCT03314935 on ClinicalTrials.gov