A Phase I, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

Sponsor:

Agios Pharmaceuticals, Inc.

Sponsor Study ID:

AG120-C-001

CTO #:

102310

NCT Number:

NCT02074839

Phase:

I

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Myeloid and Monocytic Leukemia

Study Objectives:

The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where three cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

eConsent:

Not available

Study Documents:

Open Study Documents
(MUSC NetID required for document access)