This site is intended for healthcare professionals
  • Home
  • /
  • Clinical trials
  • /
  • Uncategorised Disease
  • /
  • Study of Orally Administered AG-120 in Subjects Wi...
Clinical trial

Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

Read time: 3 mins
Last updated:1st Mar 2014
Identifier: NCT02074839

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 four 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.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 266 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
Study Start Date: March 2014
Estimated Primary Completion Date: May 2020
Estimated Study Completion Date: May 2021

Arm:
- Experimental:
AG-120

Category Value
Date last updated at source 2018-02-23
Study type(s) Interventional
Expected enrolment 266
Study start date 2014-03-01
Estimated primary completion date 2020-05-01

View full details