Description:
This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral
crenolanib versus oral placebo in combination with best supportive care in subjects with
advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120
subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching
placebo orally (PO) 3 times daily (TID) in combination with best supportive care.
Title
- Brief Title: Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST
- Official 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
Clinical Trial IDs
- ORG STUDY ID:
ARO-012
- SECONDARY ID:
2015-000287-34
- NCT ID:
NCT02847429
Conditions
- GIST With D842V Mutated PDGFRA Gene
Interventions
Drug | Synonyms | Arms |
---|
Crenolanib | Crenolanib Besylate | Crenolanib Arm |
Placebo | | Placebo Arm |
Purpose
This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral
crenolanib versus oral placebo in combination with best supportive care in subjects with
advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120
subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching
placebo orally (PO) 3 times daily (TID) in combination with best supportive care.
Trial Arms
Name | Type | Description | Interventions |
---|
Crenolanib Arm | Experimental | Investigational product (crenolanib) | |
Placebo Arm | Placebo Comparator | Matching placebo | |
Eligibility Criteria
Inclusion Criteria:
1. Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V
mutation in the PDGFRA gene as determined by central laboratory testing
2. Measurable disease as per modified RECIST 1.1
• A lesion in an area that was previously treated with local therapy (e.g. radiation,
surgery, or cryotherapy) can be considered measurable disease as long as there is
objective evidence of progression of the lesion prior to randomization
3. Subjects (male or female) ≥ 18 years of age
4. Female subjects with reproductive potential must have negative serum or urine
pregnancy test
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Exclusion Criteria:
1. Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing
cholangitis)
2. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
3. Female subject who is pregnant or breastfeeding, or planning to become pregnant within
30 days after ending treatment
4. Systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors,
immunotherapy, or investigational agents) or investigational device within 3 weeks or
5 half-lives (if the drug's half-life in subject is known) prior to randomization,
whichever is shorter
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival (PFS) will be measured from the date of randomization to the date of the first objective radiological disease progression according to centralized committee assessment using modified RECIST version 1.1 or death. |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall survival (OS) will be measured from the date of randomization to the date of death from any cause. OS will be estimated using the Kaplan-Meier method. |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Arog Pharmaceuticals, Inc. |
Last Updated
January 22, 2021