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FF-10101-01 for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Fujifilm Pharmaceuticals U.S.A., Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test the safety, tolerability, and preliminary efficacy of a new drug for people with relapsed or refractory acute myeloid leukemia.

Eligible Conditions
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1/2a: Frequency of adverse events
Secondary outcome measures
Phase 1/2a: Composite complete remission rate (CRc) including CR
Phase 1/2a: Frequency of Adverse events including assessment of 12 lead ECG.
Phase 1/2a: Frequency of Adverse events including assessment of vital signs
+24 more

Trial Design

11Treatment groups
Experimental Treatment
Group I: Cohort 8: 225 mgExperimental Treatment1 Intervention
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
Group II: Cohort 7: 150 mgExperimental Treatment1 Intervention
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
Group III: Cohort 6: 100 mgExperimental Treatment1 Intervention
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
Group IV: Cohort 5: 75 mgExperimental Treatment1 Intervention
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
Group V: Cohort 4: 50 mgExperimental Treatment1 Intervention
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
Group VI: Cohort 3: 35 mgExperimental Treatment1 Intervention
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
Group VII: Cohort 2: 20 mgExperimental Treatment1 Intervention
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
Group VIII: Cohort 22: 100 mgExperimental Treatment1 Intervention
Orally twice daily (BID) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
Group IX: Cohort 21: 75 mgExperimental Treatment1 Intervention
Orally twice daily (BID) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
Group X: Cohort 20: 50 mgExperimental Treatment1 Intervention
Orally twice daily (BID) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
Group XI: Cohort 1: 10 mgExperimental Treatment1 Intervention
Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FF-10101-01
2017
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Fujifilm Pharmaceuticals U.S.A., Inc.Lead Sponsor
8 Previous Clinical Trials
569 Total Patients Enrolled
~12 spots leftby Jun 2025
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