NCT03194685

Brief Summary

A Phase 1 dose escalation and dose ranging study of FF-10101-01 in subjects with relapsed or refractory acute myeloid leukemia to determine the safety, tolerability, PK and preliminary efficacy. A total of 9 cohorts will be enrolled in Phase 1 to establish the Maximum Tolerated Dose (MTD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2017

Longer than P75 for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

May 5, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

4.2 years

First QC Date

May 4, 2017

Last Update Submit

December 19, 2024

Conditions

AML, Adult

Keywords

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Phase 1: Frequency of adverse events

    Safety Assessments include frequency of adverse events (AEs) in percentage (%)

    12 months

Secondary Outcomes (26)

  • Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Maximum observed concentration (Cmax)

    Cycle 1, Day 1 through Cycle 2, Day 1

  • Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Time to maximum concentration (tmax)

    Cycle 1, Day 1 through Cycle 2, Day 1

  • Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Area under the plasma concentration-time curve in the sampled matrix during a 24-hour dosing interval (AUC(τ))

    Cycle 1, Day 1 through Cycle 2, Day 1

  • Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite -Plasma concentration-time curve (AUC(0-last))

    Cycle 1, Day 1 through Cycle 2, Day 1

  • Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Dose normalized AUC(τ) (AUC(τ)/dose)

    Cycle 1, Day 1 through Cycle 2, Day 1

  • +21 more secondary outcomes

Study Arms (8)

Cohort 1: 10 mg

EXPERIMENTAL

Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01

Drug: FF-10101-01

Cohort 2: 20 mg

EXPERIMENTAL

Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01

Drug: FF-10101-01

Cohort 3: 35 mg

EXPERIMENTAL

Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01

Drug: FF-10101-01

Cohort 4: 50 mg

EXPERIMENTAL

Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01

Drug: FF-10101-01

Cohort 5: 75 mg

EXPERIMENTAL

Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01

Drug: FF-10101-01

Cohort 6: 100 mg

EXPERIMENTAL

Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01

Drug: FF-10101-01

Cohort 7: 150 mg

EXPERIMENTAL

Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01

Drug: FF-10101-01

Cohort 8: 225 mg

EXPERIMENTAL

Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01

Drug: FF-10101-01

Interventions

FF-10101-01DRUG

FF-10101-01 will be administered orally once a day on Days 1-28 of a 28-day cycle. In Phase 1, the dose escalation will proceed until MTD is reached.

Also known as: FF-10101 succinate
Cohort 1: 10 mgCohort 2: 20 mgCohort 3: 35 mgCohort 4: 50 mgCohort 5: 75 mgCohort 6: 100 mgCohort 7: 150 mgCohort 8: 225 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Subjects diagnosed with acute promyelocytic leukemia
  • Subjects with Bcr-Abl positive leukemia (chronic myelogenous leukemia in blast crisis)
  • Subjects with clinically active CNS leukemia
  • Subjects with major surgery within 28 days prior to the first administration of FF-10101-01
  • Subjects with radiation therapy within 28 days prior to the first administration of FF-10101-01
  • Subjects with active malignant disease requiring therapy other than AML or myelodysplastic syndrome with transformation into AML
  • Subjects with an active uncontrolled infection
  • Subjects with a medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the subject's safety as a study subject, or that could interfere with the study objectives
  • Subjects known to have human immunodeficiency virus infection, or who have active hepatitis B or C infection as determined by serological testing
  • Subjects with congestive heart failure, New York Heart Association (NYHA) Class 3 or 4, or subjects with a past history of congestive heart failure NYHA Class 3 or 4 and in whom echocardiogram or multiple gate acquisition (MUGA) scan performed within 3 months prior to screening or at screening showed a LVEF \<40%
  • Female subjects who are pregnant or breast feeding
  • Subjects on 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) or other drugs known to have muscle toxicity
  • Subjects taking strong inhibitors of CYP3A4 will be excluded from the study unless therapeutic substitution is possible
  • Subjects taking strong inducers of CYP3A4 will be excluded from the study unless therapeutic substitution is possible
  • Use of systemic immunosuppressive agents within 14 days prior to first dose of FF-10101
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of California Los Angeles, David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

University Of California, San Francisco School of Medicine

San Francisco, California, 94143, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Hospital - Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Levis M, Perl A, Schiller G, Fathi AT, Roboz G, Wang ES, Altman J, Rajkhowa T, Ando M, Suzuki T, Subach RA, Maier G, Madden T, Johansen M, Cheung K, Kurman M, Smith C. A phase 1 study of the irreversible FLT3 inhibitor FF-10101 in relapsed or refractory acute myeloid leukemia. Blood Adv. 2024 May 28;8(10):2527-2535. doi: 10.1182/bloodadvances.2023010619.

    PMID: 38502195DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

June 21, 2017

Study Start

May 5, 2017

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

December 24, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(7)