A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-500, an oral FLT3 inhibitor, in adult patients with acute leukemia.
A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-500, an oral covalent FLT3 inhibitor, in adult patients with acute myeloid leukemia (AML), who may or may not be on Antifungals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Investigational Product
Mayo Clinic
Phoenix, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
University of California, San Francisco
San Francisco, California, United States
Evaluate the safety and tolerability of BMF-500 by incidence of Treatment Emergent Adverse Events (TEAEs).
Assessed by the NCI CTCAE version 5.0.
Time frame: At the end of each 28 Day cycle for a maximum of 32 cycles
Evaluate the safety and tolerability of BMF-500 by incidence of Serious Adverse Events (SAEs).
Assessed by the NCI CTCAE version 5.0.
Time frame: At the end of each 28 Day cycle for a maximum of 32 cycles
Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
Safety, as determined by Dose-Limiting Toxicities (clinically significant Adverse Event) within each dose level assessed NCI CTCAE version 5.0.
Time frame: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period
Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
Efficacy within each dose level as determined by composite complete remission (CRc).
Time frame: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period
Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
Pharmacovigilance (PK) at each dose level as determined by the maximum plasma concentration (Cmax).
Time frame: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period
Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
Pharmacovigilance (PK) at each dose level as determined by area under the curve plasma concentration from time 0 to last quantifiable concentration (AUClast).
Time frame: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period
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Colorado Blood Cancer Institute
Denver, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, United States
Mayo Clinic
Rochester, Minnesota, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
...and 4 more locations
Determine the pharmacokinetics of BMF-500.
Maximum plasma concentration (Cmax).
Time frame: At the end of each cycle (each cycle is 28 days in duration) for 7 cycles
Determine the pharmacokinetics of BMF-500.
Area under the curve plasma concentration from time 0 to last quantifiable concentration (AUClast).
Time frame: At the end of Cycle 1 and 2 (each cycle is 28 days in duration)
Evaluate the efficacy of BMF-500
Composite Complete Remission (CRc).
Time frame: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.
Duration of Response (DOR).
Time frame: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Evaluate the efficacy of BMF-500
Overall Reasons Rate (ORR).
Time frame: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.
Relapse free survival (RFS).
Time frame: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.
Overall Survival (OS).
Time frame: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles