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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.

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

Clinicaltrials.gov identifier NCT02543879

Recruitment Status Completed

First Posted September 7, 2015

Last update posted June 26, 2019

Study Description

Brief 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 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.

  • Condition or Disease:Non-Hodgkin Lymphoma
    Acute Myeloid Leukemia
    Acute Myelogenous Leukemia
    Myelodysplastic Syndrome
  • Intervention/Treatment: Drug: FT-1101
    Drug: Azacitidine
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 94 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Study Start Date: September 2015
  • Actual Primary Completion Date: March 2019
  • Actual Study Completion Date: March 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Dose Escalation FT-1101
Following 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.
Drug: FT-1101
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
Experimental: Dose Escalation FT-1101 + azacitidine
Following 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.
Drug: FT-1101
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

Drug: Azacitidine
Azacitidine will be administered per site's standard of care
Experimental: Dose Expansion FT-1101
Once 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
Drug: FT-1101
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
Experimental: Dose Expansion FT-1101 + azacitidine
Once 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.
Drug: FT-1101
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

Drug: Azacitidine
Azacitidine will be administered per site's standard of care
Outcome Measures
  • Primary Outcome Measures: 1. Maximum Tolerated Dose (MTD) [ Time Frame: Within first 4 weeks of treatment ]
  • 2. Dose Limiting Toxicities (DLT) [ Time Frame: Within first 4 weeks of treatment ]
  • 3. Recommended Phase 2 Dose (RP2D) [ Time Frame: Participants to be followed for duration of participation, an expected average of 12 weeks ]
  • Secondary Outcome Measures: 1. Peak Plasma Concentration (Cmax) [ Time Frame: PK collected at multiple visits during the first 30 days of treatment ]
  • 2. Area under the plasma concentration versus time curve (AUC) [ Time Frame: PK collected at multiple visits during the first 30 days of treatment ]
  • 3. Time of peak plasma concentration (TMax) [ Time Frame: 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) [ Time Frame: PK collected at multiple visits during the first 30 days of treatment ]
  • 5. Rate at which drug is removed from blood stream (CL/F) [ Time Frame: PK collected at multiple visits during the first 30 days of treatment ]
  • 6. Rate of drug distribution within the blood stream (Vd/F) [ Time Frame: 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 [ Time Frame: Assessed for duration of participation, an expected average of 12 weeks ]
  • Other Outcome Measures: 1. Assessment of on-target activity of FT-1101, as determined by changes in PD biomarkers in bone marrow aspirates and/or peripheral blood [ Time Frame: Assessed for duration of participation, an expected average of 12 weeks ]
  • 2. To determine if there is any correlation between cancer-associated genetic alterations with response [ Time Frame: Assessed for duration of participation, an expected average of 12 weeks ]
  • 3. To evaluate PK/PD relationships in dose-escalation and dose-expansion cohorts [ Time Frame: Assessed for duration of participation, an expected average of 12 weeks ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Key Inclusion Criteria:

- 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

- 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

Key Exclusion Criteria:

- 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

- 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

Contacts and Locations
Contacts
Locations

United States, California
Cedars Sinai
Los Angeles

United States, Florida
Florida Cancer Specialists
Sarasota

United States, Florida
Moffitt Cancer Center
Tampa

United States, Illinois
Northwestern University
Chicago

United States, Maryland
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore

United States, North Carolina
Levine Cancer Institute
Charlotte

United States, Tennessee
Sarah Cannon Research Institute
Nashville

United States, Texas
MD Anderson Cancer Center
Houston

Sponsors and Collaborators

Forma Therapeutics, Inc.

Investigators

Study Director: Patrick Kelly, MD Forma Therapeutics, Inc.

More Information
  • Responsible Party: Forma Therapeutics, Inc.
  • ClinicalTrials.gov Identifier: NCT02543879 History of Changes
  • Other Study ID Numbers: 1101-HEM-101
  • First Posted: September 7, 2015 Key Record Dates
  • Last Update Posted: June 26, 2019
  • Last Verified: June 2019
  • Keywords provided by Forma Therapeutics, Inc.: NHL
    AML
    BET Inhibitor
    FT-1101
    Acute Leukemia
    Myelodysplastic Syndrome
    Non-Hodgkin Lymphoma
  • Additional relevant MeSH terms: Leukemia
    Leukemia, Myeloid, Acute
    Lymphoma, Non-Hodgkin
    Hematologic Neoplasms
    Myelodysplastic Syndromes
    Preleukemia