Study of INCB053914 in Subjects With Advanced Malignancies



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/6/2019
Start Date:October 2015
End Date:January 2020
Contact:Incyte Corporation Call Center
Phone:1.855.463.3463

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A Phase 1/2 Study of INCB053914 in Subjects With Advanced Malignancies

This is an open-label, dose-escalation study of the proviral integration site of Moloney
murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced
malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation)
will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and
the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken
forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will
further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of
the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of
INCB053914 in combination with select standard of care (SOC) agents and will identify the
optimal INCB053914 dose in combination with conventional SOC regimens to take forward into
Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and
pharmacokinetics of the recommended Phase 2 dose combination(s).


Inclusion Criteria:

- Aged 18 years or older

- Confirmed diagnosis of select advanced malignancy

- Parts 1 and 2:

- Unresponsive to currently available therapy and there is no standard-of-care
therapy available in the judgment of the investigator.

- Not currently a candidate for curative treatment

- Parts 3 and 4:

- Subjects with relapsed/refractory AML must have received either induction
chemotherapy for AML or hypomethylating agents for hematologic disease before
AML.

- Elderly subjects (≥ 65 years) with newly diagnosed AML must be treatment naive
and unfit for intensive chemotherapy.

- Myelofibrosis subjects must have been treated with ruxolitinib for ≥ 6 months
with a stable dose for ≥ 8 weeks (acceptable doses are 5 mg twice daily [BID] to
25 mg BID).

- Willingness to undergo a pretreatment bone marrow biopsy and/or aspirate, or archival
sample obtained since completion of most recent therapy (as appropriate to subjects
with existing bone marrow disease or for whom bone marrow examination is a component
of disease status assessment)

- Eastern Cooperative Oncology Group (ECOG) performance status

- Part 1: 0 or 1

- Parts 2, 3 and 4: 0, 1, or 2

- Life expectancy > 12 weeks or ≥ 24 weeks for Part 3 and Part 4 MF subjects.

Exclusion Criteria:

- Inadequate bone marrow or organ function

- Received an investigational agent within 5 half-lives or 14 days, whichever is longer,
prior to receiving the first dose of study drug

- Received non-biologic anticancer medication within 5 half-lives prior to receiving the
first dose of study drug (within 6 weeks for mitomycin-C or nitrosoureas), within 28
days for any antibodies or biological therapies

- Prior receipt of a PIM inhibitor

- Any history of disease involving the central nervous system (Part 1). Known active
disease involving the central nervous system (Part 2).

- Screening corrected QT interval (QTc) interval > 470 milliseconds

- Radiotherapy within the 2 weeks prior to initiation of treatment

- Chronic or current active infection requiring systemic antibiotic, antifungal, or
antiviral treatment
We found this trial at
24
sites
New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Dr. Amer Zeidan
Phone: 203-737-6878
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Dr. Andres Forero Torres
Phone: 205-975-3198
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Dr. Michael Savona
Phone: 615-875-0072
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Dr. Rami Komrokji
Phone: 813-745-5941
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Dr. Kristen Pettit
Phone: 734-936-3879
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Atlanta, Georgia 30322
Principal Investigator: Dr. Donald R. Harvey
Phone: 404-778-5849
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Austin, Texas 78731
Principal Investigator: Dr. Jason Melear
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Austin, TX
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Dr. Maria Baer
Phone: 410-328-9161
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Boston, Massachusetts 02115
Principal Investigator: Dr. Amir T. Fathi
Phone: 617-643-5126
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Dr. Valeriy Sedov
Phone: 843-792-1463
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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675 North Saint Clair Street
Chicago, Illinois 60611
Principal Investigator: Dr. Jason Kaplan
Phone: 312-695-4198
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Cincinnati, Ohio
Principal Investigator: Dr. James Essell
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Dr. Jorge Cortes-Franco
Phone: 713-794-4258
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: Dr. Candido Rivera
Phone: 904-953-6174
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Dr. Ehab Atallah
Phone: 414-805-4600
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Dr. William Donnellan
Phone: 615-329-7423
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Oklahoma City, Oklahoma 73104
Principal Investigator: Dr. Adam Asch
Phone: 405-271-8001
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Dr. Vijaya Bhatt
Phone: 402-559-8008
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Rochester, New York 14642
Principal Investigator: Dr. Jason Mendler
Phone: 585-275-5823
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4501 X St
Sacramento, California 95817
(916) 734-5800
Principal Investigator: Dr. Brian Jonas
Phone: 916-703-5559
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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100 Medical Plaza Driveway
Santa Monica, California 90095
Principal Investigator: Dr. Sven de Vos
Phone: 310-582-4067
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Sarasota, Florida 34232
Principal Investigator: Dr. Manish Patel
Phone: 941-377-9993
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Tucson, Arizona 85724
Principal Investigator: Dr. Daniel Persky
Phone: 520-626-1183
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Tyler, Texas 75702
Principal Investigator: Dr. Donald Richards
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