Phase I Study of BAY1436032 in Isocitrate Dehydrogenase-1 (IDH1)-Mutant Advanced Solid Tumors

Phase I Study of BAY1436032 in Isocitrate Dehydrogenase-1 (IDH1)-Mutant Advanced Solid Tumors

Study Name
  Phase I Study of BAY1436032 in Isocitrate Dehydrogenase-1 (IDH1)-Mutant Advanced Solid Tumors
ClinicalTrials.gov Identifier (if applicable)
  https://www.clinicaltrials.gov/ct2/show/NCT02746081?term=IDH1&rank=6
Study Center
Institution Name
  USC Norris Comprehensive Cancer Center
Institution Address
  1441 Eastlake Ave
City
  Los Angeles
State
  California
Zip Code
  90089
Phone
  (323) 865-3967
Website
  http://www.uscnorris.com
Study Contacts
Principal Investigator
  Heinz Josef Lenz
P.I. Phone
  (323) 865-3967
P.I. Email
  lenz@usc.edu
Study Coordinator
  Jubilee Acap
Study Coordinator Phone
  (323) 865-3900
Study Coordinator Email
  jubilee.acap@med.usc.edu
OVERVIEW – in layman’s terms (150 words max)
  An Open-label, Non-Randomized (the participants are not assigned by chance to different treatment groups), Multi-center, Phase I Study.
Phase II Dose of the Orally taken Mutant IDH Inhibitor BAY 1436032. Cohorts will consist of patients representing the following IDH1-R132X-mutant intrahepatic cholangioncarcinoma, glioblastoma/ anaplastic glioma
Enrollment
  open
Study Start Date
  12/01/2016
Estimated Completion Date
  01/31/2018
Inclusion Criteria – Patients Must:
 
  • call for eligibity
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
 
  • Mutation testing for IDH1 mutations

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