NCT01905813

Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies

A Phase 1, Open-label, Dose Escalation, Safety and Tolerability Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and itacitinib (INCB039110), a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with itacitinib (INCB039110) in subjects with relapsed/refractory B-cell malignancies.

Conditions

• B-cell Malignancies

Interventions

Type	Name	Description
DRUG	INCB040093	Escalating doses starting at 100 mg every day (QD)
DRUG	INCB040093 + itacitinib	INCB040093 dose to be determined at completion of Part 1 of the study + itacitinib at a starting dose of 400 mg, QD with escalations planned up to 600 mg QD.

Timeline

• Start date: 2013-06-30
• Primary completion: 2026-04-17
• Completion: 2026-04-17
• First posted: 2013-07-23
• Last updated: 2025-12-19

Locations

6 sites across 1 country: United States