Spots Global Cancer Trial Database for An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
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Trial Identification
Brief Title: An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
Official Title: A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies
Study ID: NCT02712905
Conditions
Study Description
Brief Summary: This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the selected monotherapy dose(s) in AML/MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability, efficacy, PK, and PD of the selected combination dose(s) in Part 3.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama, Birmingham, Alabama, United States
Moores UCSD Cancer Center, La Jolla, California, United States
UCLA Medical Center, Los Angeles, California, United States
Northwestern University, Chicago, Illinois, United States
University of Kansas Center for Research, Inc., Kansas City, Kansas, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University, New York, New York, United States
Oregon Health Science University, Portland, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Vanderbilt University, Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Institut Jules Bordet, Brussel, , Belgium
Netherland Cancer Institute, Amsterdam, , Netherlands
VU Medical Center, Amsterdam, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Contact Details
Name: Fred Zheng, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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