AML, AdultPhase 1NCT03194685
Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study testing FF-10101-01 in people with AML, Adult, run by Fujifilm Pharmaceuticals U.S.A., Inc. at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Adult
- What is being tested?
- FF-10101-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 May 2017to 31 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 18Show fewer
- 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
- Subjects taking drugs known to cause Torsades de Pointes will be excluded from the study unless therapeutic substitution is possible
- Subjects known to have long QT syndrome
- Subjects with mean QTcF values following 3 ECGs conducted 5 minutes apart of >470 msec
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Johns Hopkins Hospital - Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Northwestern University
Chicago, Illinois, 60611
University of California Los Angeles, David Geffen School of Medicine
Los Angeles, California, 90095
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University Of California, San Francisco School of Medicine
San Francisco, California, 94143
About this study
Official title: A First-in-Human Phase 1 Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of FF-10101-01 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
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).
Read the detailed description
Subjects will receive FF-10101-01 orally once a day repeated every 28 days =1 cycle Frequent blood draws will be collected to measure pharmacodynamic parameters and pharmacodynamic activity.
Disease assessments, including bone marrow aspirates, will be performed at the beginning of cycles 1-3, and every 3 months thereafter. Subjects who demonstrate objective response or stable disease will be allowed to continue therapy with FF-10101-01 until , observation of unacceptable adverse events, or until the subject is no longer deriving benefit based on the opinion of the investigator.
- Conditions
- AML, Adult
- Being tested
- FF-10101-01
- Keywords
- Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FF-10101-01Drug
Also called FF-10101 succinate
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 10 mg | Experimental | Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: FF-10101-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Frequency of adverse events
Safety Assessments include frequency of adverse events (AEs) in percentage (%)
Measured: 12 months
Secondary outcomes (26)
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Maximum observed concentration (Cmax)
Maximum observed concentration (Cmax)
Measured: 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)
Time to maximum concentration (tmax)
Measured: 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))
Area under the plasma concentration-time curve in the sampled matrix during a 24-hour dosing interval (AUC(τ))
Measured: 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))
Area under the plasma concentration-time curve in the sampled matrix from time zero to the last quantifiable concentration, if concentrations are not quantifiable over the entire 24-hour dosing interval (AUC(0-last))
Measured: 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)
Dose normalized AUC(τ) (AUC(τ)/dose)
Measured: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Dose normalized Cmax (Cmax/dose)
Dose normalized Cmax (Cmax/dose)
Measured: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Accumulation ratio for AUC
Accumulation ratio for AUC [RaccAUC ie, ratio of Day 29/Day 1 of the PK parameter]
Measured: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Accumulation ratio for Cmax
Accumulation ratio for Cmax [RaccCmax ie, ratio of Day 29/Day 1 of the PK parameter]
Measured: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Oral clearance (CL/F) for FF-10101
Oral clearance (CL/F) for FF-10101
Measured: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Average concentrations (Cavg)
Average concentrations (Cavg)
Measured: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Minimum observed concentration (Cmin)
Minimum observed concentration (Cmin)
Measured: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Fluctuation index
Fluctuation index
Measured: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Metabolite (FF-10101M1) to parent (FF-10101) exposure ratios for Cmax
Metabolite (FF-10101M1) to parent (FF-10101) exposure ratios for Cmax
Measured: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Metabolite (FF-10101M1) to parent (FF-10101) exposure ratios for AUC(τ)
Metabolite (FF-10101M1) to parent (FF-10101) exposure ratios for AUC(τ)
Measured: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Frequency of Serious Adverse Events
Safety Assessments include frequency of Serious adverse events (SAEs)
Measured: 12 Months
Phase 1: Frequency of Dose Limiting Toxicities
Safety Assessments include frequency of dose-limiting toxicities (DLTs), dose reductions, delays, or withdrawals due to toxicity.
Measured: 12 Months
Phase 1: Frequency of adverse events including assessment of Hematology laboratory parameters
Safety assessments also include assessment of clinical laboratory parameters Hematology
Measured: 12 Months
Phase 1: Frequency of adverse events including assessment of serum chemistry laboratory parameters
Safety assessments also include assessment of clinical laboratory parameters serum chemistry
Measured: 12 Months
Phase 1: Frequency of adverse events including assessment of urinalysis laboratory parameters
Safety assessments also include assessment of clinical laboratory parameters urinalysis
Measured: 12 Months
Phase 1: Frequency of Adverse events including assessment of vital signs
Safety assessments also include assessment of Vital signs (Heart Rate and BP)
Measured: 12 Months
Phase 1: Frequency of Adverse events including assessment of vital signs - Heart Rate
Safety assessments also include assessment of Vital signs Heart Rate
Measured: 12 Months
Phase 1: Frequency of Adverse events including assessment of vital signs - Blood Pressure
Safety assessments also include assessment of Vital signs BP)
Measured: 12 Months
Phase 1: Frequency of Adverse events including assessment of 12 lead ECG.
Safety assessments also include assessment of 12 lead ECG.
Measured: 12 Months
Phase 1: Composite complete remission rate (CRc) including CR
Composite complete remission rate (CRc) which includes CR
Measured: 12 Months
Phase 1: Composite complete remission rate (CRc) including CR with incomplete platelet recovery (CRp)
Composite complete remission rate (CRc) which includes CR with incomplete platelet recovery (CRp)
Measured: 12 Months
Phase 1: Composite complete remission rate (CRc) including CR with incomplete neutrophil recovery with or without platelet recovery (CRi))
Composite complete remission rate (CRc) which includes CR with incomplete neutrophil recovery with or without platelet recovery (CRi))
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start5 May 2017
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AML, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194685
- Sponsor's protocol ID
- FF-10101-US101
- Status last verified
- Dec 2024
- First submitted
- 4 May 2017
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38502195
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Phase 1 Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of FF-10101-01 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03194685
- Acronym / sponsor ID
- FF-10101-US101
- Conditions
- AML, Adult
- Keywords
- Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.Industry (pharma, biotech, devices)
- Study start
- 5 May 2017 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Subjects will receive FF-10101-01 orally once a day repeated every 28 days =1 cycle Frequent blood draws will be collected to measure pharmacodynamic parameters and pharmacodynamic activity.
Disease assessments, including bone marrow aspirates, will be performed at the beginning of cycles 1-3, and every 3 months thereafter. Subjects who demonstrate objective response or stable disease will be allowed to continue therapy with FF-10101-01 until , observation of unacceptable adverse events, or until the subject is no longer deriving benefit based on the opinion of the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 10 mg | Experimental | Drug: FF-10101-01Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01 |
| Cohort 2: 20 mg | Experimental | Drug: FF-10101-01Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01 |
| Cohort 3: 35 mg | Experimental | Drug: FF-10101-01Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01 |
| Cohort 4: 50 mg | Experimental | Drug: FF-10101-01Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01 |
| Cohort 5: 75 mg | Experimental | Drug: FF-10101-01Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01 |
| Cohort 6: 100 mg | Experimental | Drug: FF-10101-01Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01 |
| Cohort 7: 150 mg | Experimental | Drug: FF-10101-01Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01 |
| Cohort 8: 225 mg | Experimental | Drug: FF-10101-01Orally once a day (QD) on Days 1-28 of a 28-day cycle. Drug: FF-10101-01 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FF-10101-01Also: FF-10101 succinateFF-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. | Drug | Cohort 1: 10 mg, Cohort 2: 20 mg, Cohort 3: 35 mg, Cohort 4: 50 mg, Cohort 5: 75 mg, Cohort 6: 100 mg, Cohort 7: 150 mg, Cohort 8: 225 mg |
Primary outcome
Phase 1: Frequency of adverse events
Time frame: 12 months
Safety Assessments include frequency of adverse events (AEs) in percentage (%)
26 secondary outcomes
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Maximum observed concentration (Cmax)
Time frame: 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)
Time frame: 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))
Time frame: 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))
Time frame: 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)
Time frame: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Dose normalized Cmax (Cmax/dose)
Time frame: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Accumulation ratio for AUC
Time frame: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Accumulation ratio for Cmax
Time frame: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Oral clearance (CL/F) for FF-10101
Time frame: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Average concentrations (Cavg)
Time frame: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Minimum observed concentration (Cmin)
Time frame: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Fluctuation index
Time frame: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Metabolite (FF-10101M1) to parent (FF-10101) exposure ratios for Cmax
Time frame: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Evaluate the Pharmacokinetic profile of FF-10101-01 and its Metabolite - Metabolite (FF-10101M1) to parent (FF-10101) exposure ratios for AUC(τ)
Time frame: Cycle 1, Day 1 through Cycle 2, Day 1
Phase 1: Frequency of Serious Adverse Events
Time frame: 12 Months
Phase 1: Frequency of Dose Limiting Toxicities
Time frame: 12 Months
Phase 1: Frequency of adverse events including assessment of Hematology laboratory parameters
Time frame: 12 Months
Phase 1: Frequency of adverse events including assessment of serum chemistry laboratory parameters
Time frame: 12 Months
Phase 1: Frequency of adverse events including assessment of urinalysis laboratory parameters
Time frame: 12 Months
Phase 1: Frequency of Adverse events including assessment of vital signs
Time frame: 12 Months
Phase 1: Frequency of Adverse events including assessment of vital signs - Heart Rate
Time frame: 12 Months
Phase 1: Frequency of Adverse events including assessment of vital signs - Blood Pressure
Time frame: 12 Months
Phase 1: Frequency of Adverse events including assessment of 12 lead ECG.
Time frame: 12 Months
Phase 1: Composite complete remission rate (CRc) including CR
Time frame: 12 Months
Phase 1: Composite complete remission rate (CRc) including CR with incomplete platelet recovery (CRp)
Time frame: 12 Months
Phase 1: Composite complete remission rate (CRc) including CR with incomplete neutrophil recovery with or without platelet recovery (CRi))
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Derived from this study: PubMed 38502195Levis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FF-10101-01 in people with AML, Adult, run by Fujifilm Pharmaceuticals U.S.A., Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Frequency of adverse events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.