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Clinical Trials/NCT02847429
NCT02847429UnknownPhase 3

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

Arog Pharmaceuticals, Inc.23 sites in 7 countries120 target enrollmentStarted: August 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Enrollment
120
Locations
23
Primary Endpoint
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.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing
  • •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
  • •Subjects (male or female) ≥ 18 years of age
  • •Female subjects with reproductive potential must have negative serum or urine pregnancy test
  • •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria

  • •Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis)
  • •Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • •Female subject who is pregnant or breastfeeding, or planning to become pregnant within 30 days after ending treatment
  • •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

Arms & Interventions

Crenolanib Arm

Experimental

Investigational product (crenolanib)

Intervention: Crenolanib (Drug)

Placebo Arm

Placebo Comparator

Matching placebo

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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.(3 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (23)

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