ARO-012 CrenoGIST - Version 2.1
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Trial of Crenolanib in Subjects with Advanced or Metastatic Gastrointestinal Stromal Tumors with a D842V Mutation in the PDGFRA Gene
IRAS ID
213446
Contact name
Bradley Chiga
Contact email
Sponsor organisation
AROG Pharmaceuticals
Eudract number
2015-000287-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
This study is being done to find out how safe and effective an investigational drug called crenolanib is, compared with a placebo, in prolonging the time people with a specific type of gastrointestinal stromal tumors (GIST) live without their GIST getting worse. This study focuses on GISTs that have a specific abnormality in a gene called PDGFRA known as the D842V mutation. There are currently no approved, active therapies for patients with this rare mutation.
Patients with advanced or metastatic GIST, that is one which has grown or developed so that it is not easily removed by surgery, and with confirmation of the D842V mutation may be eligible to participate in the research study. AROG Pharmaceuticals, the study's sponsor, will centrally confirm the D842V mutational status and disease progression for each patient at the time of enrollment.
The study, which will be taking place at a number of medical facilities around the world, will have a total of about 120 people participating, with the expected end of study as December 2019. The patients will be divided 2:1, so 67% will receive crenolanib, while 33% will receive placebo. Neither the patient, nor the study doctor and his/her study staff will know which group the patient will be in.
Each patient will take 100 mg of crenolanib or the matching placebo orally three times daily each day until the GIST worsens based on a CT or MRI scan, and the study doctor does not feel there are any other clinical benefits to taking the study drug. Each patient will have regular blood tests, pharmacokinetic tests - to examine how much study drug is in the blood, and imaging (CT or MRI) scans during the study.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0252
Date of REC Opinion
30 May 2017
REC opinion
Favourable Opinion