Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation



Status:Recruiting
Conditions:Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/1/2018
Start Date:April 2016
End Date:September 2020

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A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation

This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single
agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is
split into 2 distinct parts: a dose escalation part, which will utilize an open-label design
of FT-2102 (single agent) and FT-2102 + azacitidine (combination agent) administered via one
or more intermittent dosing schedules followed by a dose expansion part. The dose expansion
part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102
activity as well as combination activity with azacitidine or cytarabine. Following the
completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be
enrolled across 6 different cohorts, examining the effect of FT-2102 (as a single agent) and
FT-2102 + azacitidine (combination) on various AML/MDS disease states.


Inclusion Criteria:

- Pathologically proven acute myeloid leukemia (AML) or intermediate, high-risk, or very
high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization
(WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is
relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is
contraindicated or which has not adequately responded to standard therapy.

- Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site

- Good performance status

- Good kidney and liver function

Exclusion Criteria:

- Patients with symptomatic central nervous system (CNS) metastases or other tumor
location (such as spinal cord compression, other compressive mass, uncontrolled
painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention,
palliative care, surgery or radiation therapy

- Congestive heart failure (New York Heart Association Class III or IV) or unstable
angina pectoris. Previous history of myocardial infarction within 1 year prior to
study entry, uncontrolled hypertension or uncontrolled arrhythmias

- Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe
symptoms) with current medication

- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
therapy
We found this trial at
27
sites
22 South Greene Street
Baltimore, Maryland 21201
Phone: 410-328-8370
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Phone: 800-767-9355
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Phone: 615-936-1936
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-346-0227
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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Atlanta, Georgia 30322
Phone: 404-778-4334
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303 East Superior Street
Chicago, Illinois 60611
Phone: 312-472-1234
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Chicago, IL
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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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Dallas, Texas 75390
Phone: 214-648-3111
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Darlinghurst, New South Wales 2010
Phone: +61 02 8382 1111
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Detroit, Michigan 48201
Phone: 313-576-9685
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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East Setauket, New York 11733
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Hawthorne, New York 10532
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Houston, Texas 77030
Phone: 713-794-5783
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Phone: 858-822-5364
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Los Angeles, California 90095
(310) 825-4321
Phone: 310-794-0242
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
Phone: 305-243-6899
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Phone: 203-785-4699
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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630 W 168th St
New York, New York
212-305-2862
Phone: 212-304-5585
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, New York 10065
Phone: 212-746-0974
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4501 X St
Sacramento, California 95817
(916) 734-5800
Phone: 916-734-5930
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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Sarasota, Florida 34232
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Seattle, Washington 98104
Phone: 206-215-1471
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3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
Phone: 631-638-1000
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