Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML)



Status:Terminated
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:July 1, 2015
End Date:February 21, 2019

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A Phase 1b/2 Study of Entospletinib (GS-9973) Monotherapy and in Combination With Chemotherapy in Patients With Acute Myeloid Leukemia (AML)

This study will evaluate the efficacy, safety, and tolerability of entospletinib (GS-9973)
when administered as monotherapy or in combination with chemotherapy in adults with acute
myeloid leukemia (AML).


Key Inclusion Criteria:

- Adults with AML in need of treatment

- Group A : Individuals > 18 years of age with previously untreated AML who are able and
should receive up to 2 cycles of induction chemotherapy with 7+3 as determined by the
treating physician

- Group B: Individuals > 70 years of age with previously untreated AML or individuals <
70 years of age with previously untreated AML who refuse or are unable to receive
cytarabine as determined by the treating physician

- Group C: Cohort C1A: Subjects age ≥ 18 years with relapsed/refractory AML by WHO
criteria; Cohort C2: Subjects age ≥ 18 years with relapsed/refractory AML with MLL;
Cohort C3: Subjects with previously untreated AML by WHO criteria and who would have
met disease eligibility criteria for Group A or B but refuse or are unable to receive
chemotherapy and hypomethylating agent as determined by the treating physician

Key Exclusion Criteria:

- Known active central nervous system or leptomeningeal lymphoma

- Subjects with acute promyelocytic leukemia (M3)

- Treatment with proton pump inhibitors (PPIs) within 7 days prior to enrollment.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
15
sites
Durham, North Carolina 27710
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Cleveland, OH
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Detroit, Michigan 48202
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Detroit, Michigan 48201
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Fairway, KS
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Greenville, South Carolina 29607
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Los Angeles, CA
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Maywood, IL
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New York, NY
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Toronto, Ontario
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