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Study of Fosciclopirox in Patients With Relapsed/Refractory Acute Myeloid Leukemia

NCT04956042 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-02-12

No results posted yet for this study

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.

Conditions

  • Refractory Acute Myeloid Leukemia
  • Recurrent Acute Myeloid Leukemia

Interventions

DRUG

Fosciclopirox

Fosciclopirox, 900 mg/m2 administered as a 20-minute IV infusion once daily on D1-D5 of each 21-day treatment cycle

DRUG

Fosciclopirox + Cytarabine

Fosciclopirox - 900 mg/m2 administered as a 20-minute IV infusion once daily on D1-D5 of each 21-day treatment cycle Cytarabine - 1g/m2 once daily on D1-D5 of each 21-day treatment cycle

Sponsors & Collaborators

  • CicloMed LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04956042 on ClinicalTrials.gov