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ACTIVE NOT RECRUITING
NCT01905813
PHASE1

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

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

121

Start Date

2013-06-30

Completion Date

2026-04-17

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

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.

Locations (6)

Birmingham, Alabama, United States

Jacksonville, Florida, United States

Ann Arbor, Michigan, United States

Rochester, Minnesota, United States

New York, New York, United States

Rochester, New York, United States