Purpose

This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pathologically proven acute myeloid leukemia (AML) (except acute promyelocytic leukemia [APL] with the t(15;17) translocation) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy. - Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site - Good performance status - Good kidney and liver function

Exclusion Criteria

  • 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 - 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 - Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PH1 Dose Escalation & Expansion FT-2102 (olutasidenib)
  • Drug: FT-2102 (olutasidenib)
    FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Experimental
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine
  • Drug: FT-2102 (olutasidenib)
    FT-2102 (olutasidenib) will be supplied as 50 mg or 150 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
    Other names:
    • Vidaza
Experimental
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine
  • Drug: FT-2102 (olutasidenib)
    FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
  • Drug: Cytarabine
    low-dose cytarabine will be administered per site's standard of care
Experimental
PH2 Cohort 1 FT-2102 (olutasidenib) Single Agent
Relapsed or Refractory (R/R) AML
  • Drug: FT-2102 (olutasidenib)
    FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Experimental
PH2 Cohort 2 FT-2102 (olutasidenib) Single Agent
AML in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after prior therapy with residual IDH1-R132 mutation
  • Drug: FT-2102 (olutasidenib)
    FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Experimental
PH2 Cohort 3 FT-2102 (olutasidenib) Single Agent
R/R AML/MDS, previously treated with FT-2102
  • Drug: FT-2102 (olutasidenib)
    FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Experimental
PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine
R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy
  • Drug: FT-2102 (olutasidenib)
    FT-2102 (olutasidenib) will be supplied as 50 mg or 150 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
    Other names:
    • Vidaza
Experimental
PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine
R/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy
  • Drug: FT-2102 (olutasidenib)
    FT-2102 (olutasidenib) will be supplied as 50 mg or 150 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
    Other names:
    • Vidaza
Experimental
PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine
R/R AML/MDS that have been previously treated with single-agent FT-2102 as their last therapy prior to study enrollment
  • Drug: FT-2102 (olutasidenib)
    FT-2102 (olutasidenib) will be supplied as 50 mg or 150 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
    Other names:
    • Vidaza
Experimental
PH2 Cohort 7 FT-2102 (olutasidenib) Single Agent
Treatment naïve AML for whom standard treatments are contraindicated
  • Drug: FT-2102 (olutasidenib)
    FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Experimental
PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine
Treatment naïve AML who are candidates for azacitidine first line treatment
  • Drug: FT-2102 (olutasidenib)
    FT-2102 (olutasidenib) will be supplied as 50 mg or 150 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
    Other names:
    • Vidaza

Recruiting Locations

University of Maryland Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Hongxia Li
410-328-8370
hongxiali@umm.edu

More Details

Status
Recruiting
Sponsor
Forma Therapeutics, Inc.

Study Contact

Forma Therapeutics
617-679-1970
medicalinformation@formatherapeutics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.