Spots Global Cancer Trial Database for Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
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Trial Identification
Brief Title: Study of INCB040093 in Subjects With Previously Treated 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
Study ID: NCT01905813
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, 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
Contact Details
Name: Peter Langmuir, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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