CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 149 enrolled
Drug / intervention
INCB001158 +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03314935
NCT03314935Phase 2Completed
CompareCT.gov

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of INCB001158 in Combination With Chemotherapy, in Subjects With Advanced or Metastatic Solid Tumors

Incyte Corporation·interventional·Posted Oct 19, 2017·Updated Aug 12, 2025

In Brief

A Phase 2 clinical trial evaluating INCB001158, Oxaliplatin, and 5 other interventions for Biliary Tract Cancer (BTC) and 5 related conditions. Completed, enrolled 149 participants across 10 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Tract Cancer (BTC), Colorectal Cancer (CRC), Endometrial Cancer, Gastroesophageal Cancer (GC), Ovarian Cancer, Solid Tumors
CountriesBelgium, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 19, 2017
Enrollment StartNov 21, 2017
Primary CompletionNov 28, 2022
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 8.7 years ago

Interventions

INCB001158drug

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.

Oxaliplatindrug

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

Leucovorindrug

Leucovorin at the protocol-defined dose and regimen.

5-Fluorouracildrug

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

Gemcitabinedrug

Gemcitabine at the protocol-defined dose and regimen.

Cisplatindrug

Cisplatin at the protocol-defined dose and regimen.

Paclitaxeldrug

Paclitaxel at the protocol-defined dose and regimen.