Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PHI 101 for the Treatment of AML
Status:
Recruiting
Trial end date:
2022-05-21
Target enrollment:
Participant gender:
Summary
The purpose of this study is to find out the maximum tolerable dose and safety of PHI-101,
novel FLT3 inhibitor in the treatment of relapsed or refractory AML for patients who have
received standard therapy or cannot tolerate standard therapy, and/or for whom no standard
therapy exists.
There will be two parts to the study, which we will call Phase Ia and Phase Ib. Phase Ia is
called the dose escalation. Approximately 20 to 24 patients are planned to be enrolled into
Phase Ia. Phase 1a is conducted to determine the best dose and schedule of dosing of PHI-101
to be used in Phase 1b. There will be 5 different dose levels of PHI-101 given to patients in
Phase Ia.
Phase Ib is called the dose expansion. Approximately 14-34 patients (approximately 14-17
patients in each of the 2 cohorts planned) of each cohort are planned in Phase Ib based on
study design. Phase Ib is also being conducted to assess anti-leukemia response, changes in
transfusion requirements, and safety of PHI-101 at the dose level identified during Phase Ia.