An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:May 2016
End Date:March 2020
Contact:Incyte Corporation Call Center
Phone:1.855.463.3463

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A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies

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.


Inclusion Criteria:

- Male or female subjects, age 18 years or older.

- Presence of measurable disease that has been confirmed by histology or cytology.

- Must not be a candidate for potentially curative therapy or standard-of-care approved
therapy

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

- Receipt of anticancer medications, anticancer therapies, or investigational drugs
within the defined interval before the first administration of study drug.

- Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for stable
chronic toxicities (≤ Grade 2) not expected to resolve.

- Laboratory and medical history parameters outside Protocol-defined range.

- Known additional malignancy that is progressing or requires active treatment.
We found this trial at
11
sites
La Jolla, California 92093
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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Birmingham, Alabama 35294
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Birmingham, AL
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121 Boulevard de Waterloo
Brussel, 1000
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Brussel,
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Kansas City, Kansas 66101
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Kansas City, KS
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Los Angeles, CA
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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