Study of Fosciclopirox in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Status:
Recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
Summary
This will be an open-label, Phase 1B/2A, study to characterize the efficacy, safety,
pharmacokinetics, and pharmacodynamics of fosciclopirox administered alone and in combination
with cytarabine in patients with R/R AML with up to two cohorts studied to confirm the
efficacy (or futility) of fosciclopirox on the endpoint of disease response.
Initially, 14 evaluable patients will be enrolled in Cohort 1a. If disease response to
fosciclopirox alone IS observed in at least 4 of 14 patients, an additional 14 patients will
be enrolled in Cohort 1b. If disease response to fosciclopirox alone IS NOT observed in at
least 4 of 14 patients in Cohort 1a, based on a review of all available study data, the study
may be terminated OR a Cohort 2a may be initiated using the combination of fosciclopirox and
cytarabine. If disease response to fosciclopirox in combination with cytarabine IS observed
in at least 4 of 14 patients in Cohort 2a, an additional 14 patients will be enrolled in
Cohort 2b. If disease response to fosciclopirox in combination with cytarabine IS NOT
observed in at least 4 of 14 patients in the Cohort 2a, the study will be stopped for
futility.