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Acute Myeloid LeukemiaPhase 1NCT02543879

Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies

A Phase 1 study testing FT-1101 and Azacitidine in people with Acute Myeloid Leukemia and Acute Myelogenous Leukemia, run by Forma Therapeutics, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an open-label, multicenter, dose-escalation Phase 1/1b study in patients with acute myelogenous leukemia (AML)/MDS or non-Hodgkin Lymphoma (NHL), intended to investigate safety, pharmacokinetics, and the pharmacodynamic effects of FT-1101 administered via one or more intermittent dosing schedules alone and in… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FT-1101 and Azacitidine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
8 sitesUnited States
Study dates
Sep 2015to Mar 2019
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

  • Single agent (SA) Dose Escalation: Histologically or cytologically proven acute leukemia or high-risk MDS as defined by the World Health Organization (WHO) criteria and IPSS-R, respectively, that is relapsed or refractory (R/R) to standard therapy or for whom standard treatments are contraindicated, OR
  • Mature B-Cell non-Hodgkin Lymphoma that is Relapsed/Refractory to standard therapy
  • AML SA expansion group 1: histologically or cytologically proven AML with a FLT3 ITD or TKD mutation previously determined by local testing that is R/R to standard therapy or for whom standard treatments are contraindicated
  • AML SA expansion group 2: histologically or cytologically proven AML with intermediate or unfavorable risk cytogenetics in the absence of a detectable FLT3 ITD or TKD mutation as previously determined by local testing that is R/R to standard therapy or for whom standard treatments are contraindicated
  • NHL SA expansion: Mature B-cell NHL with the following histologies: primary mediastinal lymphoma, DLBCL, and B-cell lymphoma not specified that is R/R to standard therapy and for whom standard treatments are contraindicated or unavailable
  • AML/MDS combination treatment (dose escalation and expansion): histologically or cytologically proven AML or MDS as defined by WHO criteria and IPSS-R, respectively, that is: R/R to standard therapy, or AML: who are unfit for, or unwilling to receive standard induction therapy, or MDS: eligible to receive azacitidine
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  • Patients ≥ 18 years old
  • Good kidney and liver function
  • No prior organ allograft
  • For fertile men and women, agreement to use effective contraceptive methods duration of study participation and 90 days after

Who cannot join

  • History of prior malignancy unless disease free for > or equal to 12 months or considered surgically cured.
  • Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
  • Treatment with major surgery (requiring general anesthesia) within one month prior to study entry
  • Previous treatment with any prior BET inhibitor therapy
  • Patients unable to swallow oral medications, or patients with gastrointestinal conditions (e.g. malabsorption, gastric or small bowel resection, etc.) deemed to jeopardize intestinal absorption
  • Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias
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  • Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication
  • Known HIV positivity
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of Maryland, Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Northwestern University

    Chicago, Illinois, 60611

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Cedars Sinai

    Los Angeles, California, 90048

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

  • Moffitt Cancer Center

    Tampa, Florida, 23985

Other trials in United States

About this study

Official title: A Phase 1/1b Dose Escalation, Multicenter, Open-label, Safety, Pharmacokinetic and Pharmacodynamic Study of FT-1101 as a Single Agent and in Combination With Azacitidine in Patients With Relapsed or Refractory Hematologic Malignancies

This is an open-label, multicenter, dose-escalation Phase 1/1b study in patients with acute myelogenous leukemia (AML)/MDS or non-Hodgkin Lymphoma (NHL), intended to investigate safety, pharmacokinetics, and the pharmacodynamic effects of FT-1101 administered via one or more intermittent dosing schedules alone and in combination with azacitidine. Once the MTD has been established for a treatment cohort, up to 20 additional patients may be enrolled in up to 4 expansion cohorts each of select populations of patients with either AML/MDS or NHL at the recommended dose for future studies to confirm safety.

Being tested
FT-1101, Azacitidine
Keywords
AML, BET Inhibitor, FT-1101, Acute Leukemia, Myelodysplastic Syndrome, NHL, Non-Hodgkin Lymphoma
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FT-1101Drug

    Also called FT1101

    FT-1101 will be supplied as 5 mg, 20 mg or 100 mg capsules and will be administered per the protocol defined frequency and dose level

  • AzacitidineDrug

    Azacitidine will be administered per site's standard of care

Study groups in NCT02543879
Study groupRoleWhat they receive
Dose Escalation FT-1101ExperimentalFollowing a 3+3 dose escalation strategy, the first cohort of patients will be administered FT-1101 at 10 mg, oral capsules, once weekly on a continuous basis. Subsequent cohorts dose and frequency will be determined by investigators and sponsor following observations of previous cohorts. Dose escalation will continue until the MTD is determined.
Receives: Drug: FT-1101
Dose Expansion FT-1101ExperimentalOnce the MTD is determined, the Recommended Phase 2 Dose (RP2D) will be identified. 3 Expansion cohorts of up to 20 patients each will be treated with the RP2D of FT-1101
Receives: Drug: FT-1101
Dose Escalation FT-1101 + azacitidineExperimentalFollowing a 3+3 dose escalation strategy, the first cohort of AML/MDS patients will be administered FT-1101 at approximately 50% or lower than the MTD identified for the single agent FT-1101. Subsequent cohorts dose will be determined by investigators and sponsor following observations of previous cohorts. Dose escalation will not exceed the dose determined to be the single agent MTD for that schedule.
Receives: Drug: FT-1101; Drug: Azacitidine
Dose Expansion FT-1101 + azacitidineExperimentalOnce the MTD is determined, the Recommended Phase 2 Dose (RP2D) will be identified. 1 Expansion cohorts of up to 20 AML/MDS patients each will be treated with the RP2D of FT-1101 in combination with azacitidine.
Receives: Drug: FT-1101; Drug: Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    Measured: Within first 4 weeks of treatment

  2. Dose Limiting Toxicities (DLT)

    Measured: Within first 4 weeks of treatment

  3. Recommended Phase 2 Dose (RP2D)

    Measured: Participants to be followed for duration of participation, an expected average of 12 weeks

Secondary outcomes (7)

  1. Area under the plasma concentration versus time curve (AUC)

    Measured: PK collected at multiple visits during the first 30 days of treatment

  2. Peak Plasma Concentration (Cmax)

    Measured: PK collected at multiple visits during the first 30 days of treatment

  3. Time of peak plasma concentration (TMax)

    Measured: PK collected at multiple visits during the first 30 days of treatment

  4. Time for half of the drug to be absent in blood stream following dose (T 1/2)

    Measured: PK collected at multiple visits during the first 30 days of treatment

  5. Rate at which drug is removed from blood stream (CL/F)

    Measured: PK collected at multiple visits during the first 30 days of treatment

  6. Rate of drug distribution within the blood stream (Vd/F)

    Measured: PK collected at multiple visits during the first 30 days of treatment

  7. Observe patients for any evidence of anti-leukemic or anti-myelodysplastic activity of FT-1101

    Measured: Assessed for duration of participation, an expected average of 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionMar 2019
  4. Study completionMar 2019

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02543879
Sponsor's protocol ID
1101-HEM-101
Status last verified
Nov 2023
First submitted
1 Sep 2015
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
No

Publications

  • Crymes A, Evans MG, Jeyakumar D, Lou JJ, Zhao X, Rezk SA. Acute Myeloid Leukemia (AML) With T-Cell Differentiation Arising From Chronic Myelomonocytic Leukemia (CMML). Case Rep Hematol. 2024 Dec 14;2024:5584297. doi: 10.1155/crh/5584297. eCollection 2024.

    PubMed 39734743

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FT-1101 and Azacitidine in people with Acute Myeloid Leukemia and Acute Myelogenous Leukemia, run by Forma Therapeutics, Inc. at 8 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 10 inclusion and 9 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 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

Maximum Tolerated Dose (MTD) (time frame: Within first 4 weeks of treatment). The study lists 3 primary outcomes in all. 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 NCT02543879, 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 21 Nov 2023.

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