At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed AML (excluding APL with t(15;17)) or intermediate/high-risk/very high-risk MDS that is relapsed/refractory to standard therapy, contraindicated for standard therapy, or inadequately responsive to standard therapy
- ✓Documented IDH1-R132 gene mutation confirmed by site testing
- ✓Good performance status
- ✓Good kidney and liver function
- ✕Symptomatic CNS metastases or other tumor locations (spinal cord compression, compressive mass, uncontrolled painful lesion, bone fracture) requiring urgent therapeutic intervention, palliative care, surgery, or radiation therapy
- ✕Congestive heart failure (NYHA Class III or IV) or unstable angina pectoris
- ✕Myocardial infarction within 1 year prior to study entry, uncontrolled hypertension, or uncontrolled arrhythmias
- ✕Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation
In Brief
A Phase 1 clinical trial evaluating FT-2102 (olutasidenib), Azacitidine, and 1 other intervention for Acute Myeloid Leukemia and 2 related conditions. Completed, enrolled 336 participants across 60 sites in 9 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Relapsed or Refractory (R/R) AML
AML in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after prior therapy with residual IDH1-R132 mutation
R/R AML/MDS, previously treated with FT-2102
R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy
R/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy
R/R AML/MDS that have been previously treated with single-agent FT-2102 as their last therapy prior to study enrollment
Treatment naïve AML for whom standard treatments are contraindicated
Treatment naïve AML who are candidates for azacitidine first line treatment
Interventions
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
azacitidine will be administered per site's standard of care
low-dose cytarabine will be administered per site's standard of care