An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
NCT ID: NCT02712905
Last Updated: 2025-11-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
116 participants
INTERVENTIONAL
2016-05-05
2022-04-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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INCB059872
INCB059872
Initial cohort dose of INCB059872 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose(s) will be taken forward into expansion cohorts.
INCB059872 tablets to be administered by mouth.
INCB059872 in combination with other therapies
Initial cohort dose of INCB059872 to evaluate different doses of INCB0599872 in combination with other therapies in the following treatment groups:
* Combination with all-trans retinoic acid (ATRA) in subjects with relapsed/refractory AML.
* Combination with azacitidine in subjects with newly diagnosed, treatment-naive AML
* Combination with nivolumab in subjects with advanced SCLC previously progressed on platinum-based treatment.
Upon identification of the recommended dose(s) for each treatment combination, expansion cohorts of approximately 30 subjects in each treatment group may begin enrollment to further determine safety, tolerability, efficacy, PK, and PD of the selected dose(s).
INCB059872
Initial cohort dose of INCB059872 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose(s) will be taken forward into expansion cohorts.
INCB059872 tablets to be administered by mouth.
all-trans retinoic acid (ATRA)
azacitidine
nivolumab
Interventions
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INCB059872
Initial cohort dose of INCB059872 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose(s) will be taken forward into expansion cohorts.
INCB059872 tablets to be administered by mouth.
all-trans retinoic acid (ATRA)
azacitidine
nivolumab
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Fred Zheng, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Vanderbilt University
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Institut Jules Bordet
Brussels, , Belgium
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
Netherland Cancer Institute
Amsterdam, , Netherlands
VU Medical Center
Amsterdam, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-001710-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 59872-101
Identifier Type: -
Identifier Source: org_study_id
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