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

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ClinicalTrials.gov Identifier: NCT02712905
Recruitment Status : Recruiting
First Posted : March 18, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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.

Condition or disease Intervention/treatment Phase
Solid Tumors and Hematologic Malignancy Drug: INCB059872 Drug: all-trans retinoic acid (ATRA) Drug: azacitidine Drug: nivolumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 215 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies
Study Start Date : May 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: INCB059872 Drug: 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.


Experimental: 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).

Drug: 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.


Drug: all-trans retinoic acid (ATRA)
Drug: azacitidine
Drug: nivolumab



Primary Outcome Measures :
  1. Safety and tolerability of INCB059872 in monotherapy and in combination with other therapies as measured by the frequency, duration, and severity of adverse events (AEs) in participants, and determine recommended dose(s) for further study [ Time Frame: AEs assessed from screening through 30 days after end of treatment, up to 6 months ]

Secondary Outcome Measures :
  1. Tumor response rates in subjects with measurable disease [ Time Frame: Tumor response at protocol-defined intervals from baseline through end of treatment, up to approximately 6 months ]
  2. Maximum observed plasma concentration (Cmax) of INCB059872 [ Time Frame: 0.5, 1, 2, 4, 6 hours postdose on Days 1 and 15 in treatment Cycle 1 and for food effect in Cycle 2, up to approximately 1 month ]
  3. Area under the single-dose plasma concentration-time curve (AUC0-t) of INCB059872 [ Time Frame: 0.5, 1, 2, 4, 6 hours postdose on Days 1 and 15 in treatment Cycle 1 and for food effect in Cycle 2, up to approximately 1 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712905


Contacts
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Contact: Incyte Corporation Call Center 1.855.463.3463

Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35487
United States, California
Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60208
United States, Kansas
University of Kansas Center for Research, Inc. Recruiting
Kansas City, Kansas, United States, 66045
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Columbia University Recruiting
New York, New York, United States, 10027
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37240
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Belgium
Institut Jules Bordet Recruiting
Brussel, Belgium
Netherlands
Netherland Cancer Institute Active, not recruiting
Amsterdam, Netherlands
VU Medical Center Active, not recruiting
Amsterdam, Netherlands
Erasmus MC Withdrawn
Rotterdam, Netherlands
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Fred Zheng, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02712905     History of Changes
Other Study ID Numbers: INCB 59872-101
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Keywords provided by Incyte Corporation:
Acute myeloid leukemia (AML)
myelodysplastic syndrome (MDS)
small cell lung cancer (SCLC)
myelofibrosis (MF)
solid tumor, lysine-specific demethylase 1 (LSD1) inhibitor

Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Azacitidine
Tretinoin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Keratolytic Agents
Dermatologic Agents