CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
FF-10501-01drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02193958
NCT02193958Phase 2Completed
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A Phase 1/2a, Dose Escalation Study of FF-10501-01 for the Treatment of Advanced Hematologic Malignancies

Fujifilm Pharmaceuticals U.S.A., Inc.·interventional·Posted Jul 18, 2014·Updated Mar 19, 2025

In Brief

A Phase 2 clinical trial evaluating FF-10501-01 for AML and 2 related conditions. Completed, enrolled 55 participants across 2 sites.

Detailed Summary

A Phase 1/2a Dose Escalation Study of FF-10501-01 in Patients with Relapsed or Refractory Hematological Malignancies to determine the safety and tolerability. A total of 6 cohorts will be enrolled in Phase 1 to establish the MTD. A total of 20 subjects with MDS/CMML treated at the RP2D are planned, including MDS/CMML subjects treated at the RP2D in Phase 1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAML, CMML, MDS
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 18, 2014
Enrollment StartJul 1, 2014
Primary CompletionAug 9, 2019
Study CompletionOct 15, 2019
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 12.0 years ago

Interventions

FF-10501-01drug

FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6), Days 1-21 of a 28-say cycle (Cohort 7), Days 1-28 of a 28-day cycle (Cohort 8) or Days 1-21 of a 28-say cycle (Cohort 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.