Phase II Study of combination of Trametinib (MEK inhibitor) and Hydroxychloroquine (HCQ) (autophagy inhibitor) in Patients with KRAS Mutation Refractory Bile Tract Carcinoma (BTC)

Study Name
Phase II Study of combination of Trametinib (MEK inhibitor) and Hydroxychloroquine (HCQ) (autophagy inhibitor) in Patients with KRAS Mutation Refractory Bile Tract Carcinoma (BTC).
ClinicalTrials.gov Identifier (if applicable)
NCT04566133
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Targeted Therapy
Study Center
Institution Name
National Cancer Institute
Institution Address
10 Center Drive
City
Bethesda
State
Maryland
Zip Code
20892
Country
United States
Phone
(240) 858-3155
Website
https://ccr.cancer.gov/staff-directory/tim-f-greten
Study Contacts
Principal Investigator
Tim Greten
P.I. Phone
(240) 760-6114
P.I. Email
tim.greten@nih.gov
Study Coordinator
Donna Mabry
Study Coordinator Phone
(240) 858-3155
Study Coordinator Email
donna.mabry@nih.gov
OVERVIEW – in layman’s terms (150 words max)
We test a combination of trametinib and hydroxychloroquine (HCQ) as systemic treatment in patients with KRAS mutated bile duct cancer.
Treatment is free at NIH.
Travel costs will be paid for.
Enrollment
open
Study Start Date
07/15/2021
Estimated Completion Date
08/31/2022
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • increase overall survival
Inclusion Criteria – Patients Must:
  • kras mutation
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • tumor sampling can be performed at NIH