Trials / Completed
CompletedNCT03314935
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 149 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Biliary Tract Cancer (BTC)
- Colorectal Cancer (CRC)
- Endometrial Cancer
- Gastroesophageal Cancer (GC)
- Ovarian Cancer
- Solid Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-11-21
- Primary completion
- 2022-11-28
- Completion
- 2022-11-28
- First posted
- 2017-10-19
- Last updated
- 2025-08-12
- Results posted
- 2023-12-07
Locations
10 sites across 3 countries: United States, Belgium, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03314935. Inclusion in this directory is not an endorsement.