Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation

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Forma Therapeutics

Status and phase

Completed
Phase 2
Phase 1

Conditions

Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia

Treatments

Drug: Cytarabine
Drug: FT-2102 (olutasidenib)
Drug: Azacitidine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02719574
2102-HEM-101

Details and patient eligibility

About

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.

Enrollment

336 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

336 participants in 11 patient groups

PH1 Dose Escalation & Expansion FT-2102 (olutasidenib)
Experimental group
Treatment:
Drug: FT-2102 (olutasidenib)
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine
Experimental group
Treatment:
Drug: Azacitidine
Drug: FT-2102 (olutasidenib)
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine
Experimental group
Treatment:
Drug: FT-2102 (olutasidenib)
Drug: Cytarabine
PH2 Cohort 1 FT-2102 (olutasidenib) Single Agent
Experimental group
Description:
Relapsed or Refractory (R/R) AML
Treatment:
Drug: FT-2102 (olutasidenib)
PH2 Cohort 2 FT-2102 (olutasidenib) Single Agent
Experimental group
Description:
AML in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after prior therapy with residual IDH1-R132 mutation
Treatment:
Drug: FT-2102 (olutasidenib)
PH2 Cohort 3 FT-2102 (olutasidenib) Single Agent
Experimental group
Description:
R/R AML/MDS, previously treated with FT-2102
Treatment:
Drug: FT-2102 (olutasidenib)
PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine
Experimental group
Description:
R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy
Treatment:
Drug: Azacitidine
Drug: FT-2102 (olutasidenib)
PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine
Experimental group
Description:
R/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy
Treatment:
Drug: Azacitidine
Drug: FT-2102 (olutasidenib)
PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine
Experimental group
Description:
R/R AML/MDS that have been previously treated with single-agent FT-2102 as their last therapy prior to study enrollment
Treatment:
Drug: Azacitidine
Drug: FT-2102 (olutasidenib)
PH2 Cohort 7 FT-2102 (olutasidenib) Single Agent
Experimental group
Description:
Treatment naïve AML for whom standard treatments are contraindicated
Treatment:
Drug: FT-2102 (olutasidenib)
PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine
Experimental group
Description:
Treatment naïve AML who are candidates for azacitidine first line treatment
Treatment:
Drug: Azacitidine
Drug: FT-2102 (olutasidenib)

Trial contacts and locations

60

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Data sourced from clinicaltrials.gov

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