NCT02559492

Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors

A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of INCB Combinations in Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid tumors. The study will be divided into 3 parts (Part 1a, Part 1b, and Part 2). Part 1a will evaluate a JAK inhibitor with JAK1 selectivity (Itacitinib) in combination with an IDO1 inhibitor (epacadostat; INCB024360; Group A) and Itacitinib in combination with a PI3K-delta inhibitor (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b doses for each combination. Once the recommended dose has been identified for each treatment group in Part 1a, subjects with advanced solid tumors will be enrolled into expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b). In Part 2, additional expansion cohorts will be enrolled to further evaluate lower doses of itacitinib and INCB050465 in subjects with select tumor types.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Itacitinib	Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.
DRUG	Epacadostat	Epacadostat tablets will be administered orally, twice daily.
DRUG	Itacitinib	Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.
DRUG	INCB050465	INCB050465 tablets will be administered orally once daily.

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-09-10
• Completion: 2019-08-18
• First posted: 2015-09-24
• Last updated: 2019-09-25

Locations

11 sites across 1 country: United States