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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02543879
Other study ID # 1101-HEM-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2015
Est. completion date March 2019

Study information

Verified date November 2023
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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
Azacitidine
Azacitidine will be administered per site's standard of care

Locations

Country Name City State
United States University of Maryland, Greenebaum Comprehensive Cancer Center Baltimore Maryland
United States Levine Cancer Institute Charlotte North Carolina
United States Northwestern University Chicago Illinois
United States MD Anderson Cancer Center Houston Texas
United States Cedars Sinai Los Angeles California
United States Sarah Cannon Research Institute Nashville Tennessee
United States Florida Cancer Specialists Sarasota Florida
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Forma Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Assessment of on-target activity of FT-1101, as determined by changes in PD biomarkers in bone marrow aspirates and/or peripheral blood Assessed for duration of participation, an expected average of 12 weeks
Other To determine if there is any correlation between cancer-associated genetic alterations with response Assessed for duration of participation, an expected average of 12 weeks
Other To evaluate PK/PD relationships in dose-escalation and dose-expansion cohorts Assessed for duration of participation, an expected average of 12 weeks
Primary Maximum Tolerated Dose (MTD) Within first 4 weeks of treatment
Primary Dose Limiting Toxicities (DLT) Within first 4 weeks of treatment
Primary Recommended Phase 2 Dose (RP2D) Participants to be followed for duration of participation, an expected average of 12 weeks
Secondary Area under the plasma concentration versus time curve (AUC) PK collected at multiple visits during the first 30 days of treatment
Secondary Peak Plasma Concentration (Cmax) PK collected at multiple visits during the first 30 days of treatment
Secondary Time of peak plasma concentration (TMax) PK collected at multiple visits during the first 30 days of treatment
Secondary Time for half of the drug to be absent in blood stream following dose (T 1/2) PK collected at multiple visits during the first 30 days of treatment
Secondary Rate at which drug is removed from blood stream (CL/F) PK collected at multiple visits during the first 30 days of treatment
Secondary Rate of drug distribution within the blood stream (Vd/F) PK collected at multiple visits during the first 30 days of treatment
Secondary Observe patients for any evidence of anti-leukemic or anti-myelodysplastic activity of FT-1101 Assessed for duration of participation, an expected average of 12 weeks
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