TP-0903 for the Treatment of FLT3 Mutated Acute Myeloid Leukemia
NCT04518345 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2023-02-06
Summary
This phase IB/II trial studies the best dose of TP-0903 and how well it works when given alone or with azacitidine in treating patients with FLT3 gene mutated acute myeloid leukemia. TP-0903 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving TP-0903 alone or with azacitidine may kill more cancer cells.
Conditions
- Acute Myeloid Leukemia
- Secondary Acute Myeloid Leukemia
- Therapy-Related Acute Myeloid Leukemia
Interventions
- DRUG
-
Given IV
- DRUG
-
Dubermatinib
Given PO
Sponsors & Collaborators
-
Sumitomo Pharma America, Inc.
collaborator INDUSTRY -
Uma Borate
lead OTHER
Principal Investigators
-
Uma Borate, MD · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-05
- Primary Completion
- 2021-10-13
- Completion
- 2021-12-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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