Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Industrial
Disease
Leukemia/heme
Enrollment Eligibility
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