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.

Forma Therapeutics, Inc.0 sites335 target enrollmentDecember 19, 2017

ConditionsRelapsed/refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).MedDRA version: 21.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10060558Term: Acute myeloid leukemia recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

DrugsVidaza

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed/refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).
Sponsor: Forma Therapeutics, Inc.
Enrollment: 335
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 19, 2017

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Forma Therapeutics, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Pathologically proven AML (except acute promyelocytic leukemia with the t(15;17\) translocation) or intermediate, high risk or very high risk MDS as defined by the World Health Organization (WHO) criteria or
•Revised International Prognostic Scoring System (IPSS\-R) harboring IDH1\-R132 mutations, and one of the following based on enrollment stage or treatment cohort:
•a. Single Agent Phase 1 Cohorts including Dose\-Escalation/Dose\-Expansion: AML/MDS either R/R to standard therapy, or for whom standard treatments are contraindicated
•b. Combination (FT\-2102 \+ azacitidine) Phase 1 Dose\-Escalation/ Dose\-Expansion (patients must meet one of the following):
•i. Patients with AML that is either R/R to standard therapy, or for whom standard treatments are contraindicated
•ii. Patients that have MDS that is either R/R to standard therapy, or are treatment\-naïve, who are eligible for azacitidine therapy
•c. Combination (FT\-2102 \+ Cytarabine) Phase 1 Dose\-Escalation/Dose\- Expansion Cohort: Patients \= 60 years with treatment\-naïve AML for whom standard treatments are contraindicated
•d. Phase 2 Cohort 1 (Single Agent) only: AML R/R to standard therapy
•e. Phase 2 Cohort 2 (Single Agent) only: AML in morphologic CR/CRi after prior therapy (\+/\- HSCT) with residual IDH1\-R132 mutation (\= 0\.01%) detected in the bone marrow
•f. Phase 2 Cohort 3 (Single Agent) only: R/R AML/MDS that have been previously treated with FT\-2102 AND for whom standard treatments are contraindicated

Exclusion Criteria

•1\. Phase 1 single agent dose\-escalation/dose expansion cohorts and Phase 2 Cohorts 1, 4, 5, 7 and 8 only: Patients who have been treated with an IDH1 targeted therapy
•2\. Phase 2 Single Agent Cohorts 1\-3 and 7 only: Patients with IDH2 mutation detection at baseline or history of IDH2m inhibitor treatment
•3\. History of prior malignancy unless disease\-free for \= 12 months or considered surgically cured; patients with nonmelanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis
•(including concomitant diagnoses)
•4\. 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
•5\. Patients with previous allogeneic HSCT if they meet any of the following criteria: \< 100 days from time of HSCT; active acute or chronic graft vs. host disease (GvHD); or receiving immunosuppressive therapy as
•treatment or prophylaxis against GvHD
•Note: Doses \< 20 mg methylprednisolone (or its equivalent) daily are not an exclusion criterion.
•6\. Treatment with radiation therapy, major surgery (requiring general anesthesia) within one month prior to study drug dosing