Clinical Trials /

Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

NCT02847429

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.

Related Conditions:
  • Gastrointestinal Stromal Tumor
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

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
  • NCT ID: NCT02847429

Conditions

  • GIST With D842V Mutated PDGFRA Gene

Interventions

DrugSynonymsArms
CrenolanibCrenolanib BesylateCrenolanib Arm
PlaceboPlacebo 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

NameTypeDescriptionInterventions
Crenolanib ArmExperimentalInvestigational product (crenolanib)
  • Crenolanib
Placebo ArmPlacebo ComparatorMatching placebo
  • 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:Recruiting
Lead Sponsor:Arog Pharmaceuticals, Inc.

Last Updated

December 5, 2017