MedTrace Logo

Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

NCT02847429 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-01-22

No results posted yet for this study

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.

Conditions

  • GIST With D842V Mutated PDGFRA Gene

Interventions

DRUG

Crenolanib

DRUG

Placebo

Sponsors & Collaborators

  • Centre Leon Berard

    collaborator OTHER

  • Fox Chase Cancer Center

    collaborator OTHER

  • Arog Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jean-Yves Blay, MD · Centre Leon Berard

  • Margaret von Mehren, MD · Fox Chase Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • United States
  • France
  • Germany
  • Italy
  • Norway
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02847429 on ClinicalTrials.gov