Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT ID: NCT03194685
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
97 participants
INTERVENTIONAL
2017-05-05
2021-07-31
Brief Summary
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Detailed Description
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Disease assessments, including bone marrow aspirates, will be performed at the beginning of cycles 1-3, and every 3 months thereafter. Subjects who demonstrate objective response or stable disease will be allowed to continue therapy with FF-10101-01 until , observation of unacceptable adverse events, or until the subject is no longer deriving benefit based on the opinion of the investigator.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1: 10 mg
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
FF-10101-01
FF-10101-01 will be administered orally once a day on Days 1-28 of a 28-day cycle. In Phase 1, the dose escalation will proceed until MTD is reached.
Cohort 2: 20 mg
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
FF-10101-01
FF-10101-01 will be administered orally once a day on Days 1-28 of a 28-day cycle. In Phase 1, the dose escalation will proceed until MTD is reached.
Cohort 3: 35 mg
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
FF-10101-01
FF-10101-01 will be administered orally once a day on Days 1-28 of a 28-day cycle. In Phase 1, the dose escalation will proceed until MTD is reached.
Cohort 4: 50 mg
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
FF-10101-01
FF-10101-01 will be administered orally once a day on Days 1-28 of a 28-day cycle. In Phase 1, the dose escalation will proceed until MTD is reached.
Cohort 5: 75 mg
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
FF-10101-01
FF-10101-01 will be administered orally once a day on Days 1-28 of a 28-day cycle. In Phase 1, the dose escalation will proceed until MTD is reached.
Cohort 6: 100 mg
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
FF-10101-01
FF-10101-01 will be administered orally once a day on Days 1-28 of a 28-day cycle. In Phase 1, the dose escalation will proceed until MTD is reached.
Cohort 7: 150 mg
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
FF-10101-01
FF-10101-01 will be administered orally once a day on Days 1-28 of a 28-day cycle. In Phase 1, the dose escalation will proceed until MTD is reached.
Cohort 8: 225 mg
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
FF-10101-01
FF-10101-01 will be administered orally once a day on Days 1-28 of a 28-day cycle. In Phase 1, the dose escalation will proceed until MTD is reached.
Interventions
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FF-10101-01
FF-10101-01 will be administered orally once a day on Days 1-28 of a 28-day cycle. In Phase 1, the dose escalation will proceed until MTD is reached.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* Subjects with Bcr-Abl positive leukemia (chronic myelogenous leukemia in blast crisis)
* Subjects with clinically active CNS leukemia
* Subjects with major surgery within 28 days prior to the first administration of FF-10101-01
* Subjects with radiation therapy within 28 days prior to the first administration of FF-10101-01
* Subjects with active malignant disease requiring therapy other than AML or myelodysplastic syndrome with transformation into AML
* Subjects with an active uncontrolled infection
* Subjects with a medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the subject's safety as a study subject, or that could interfere with the study objectives
* Subjects known to have human immunodeficiency virus infection, or who have active hepatitis B or C infection as determined by serological testing
* Subjects with congestive heart failure, New York Heart Association (NYHA) Class 3 or 4, or subjects with a past history of congestive heart failure NYHA Class 3 or 4 and in whom echocardiogram or multiple gate acquisition (MUGA) scan performed within 3 months prior to screening or at screening showed a LVEF \<40%
* Female subjects who are pregnant or breast feeding
* Subjects on 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) or other drugs known to have muscle toxicity
* Subjects taking strong inhibitors of CYP3A4 will be excluded from the study unless therapeutic substitution is possible
* Subjects taking strong inducers of CYP3A4 will be excluded from the study unless therapeutic substitution is possible
* Use of systemic immunosuppressive agents within 14 days prior to first dose of FF-10101
* Subjects taking drugs known to cause Torsades de Pointes will be excluded from the study unless therapeutic substitution is possible
* Subjects known to have long QT syndrome
* Subjects with mean QTcF values following 3 ECGs conducted 5 minutes apart of \>470 msec
18 Years
ALL
No
Sponsors
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Fujifilm Pharmaceuticals U.S.A., Inc.
INDUSTRY
Responsible Party
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Locations
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University of California Los Angeles, David Geffen School of Medicine
Los Angeles, California, United States
University Of California, San Francisco School of Medicine
San Francisco, California, United States
Northwestern University
Chicago, Illinois, United States
Johns Hopkins Hospital - Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Levis M, Perl A, Schiller G, Fathi AT, Roboz G, Wang ES, Altman J, Rajkhowa T, Ando M, Suzuki T, Subach RA, Maier G, Madden T, Johansen M, Cheung K, Kurman M, Smith C. A phase 1 study of the irreversible FLT3 inhibitor FF-10101 in relapsed or refractory acute myeloid leukemia. Blood Adv. 2024 May 28;8(10):2527-2535. doi: 10.1182/bloodadvances.2023010619.
Other Identifiers
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FF-10101-US101
Identifier Type: -
Identifier Source: org_study_id