Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

Phase 3

• Conditions: GIST With D842V Mutated PDGFRA Gene
• Interventions: Drug: Placebo; Drug: Crenolanib

• Registration Number: NCT02847429
• Lead Sponsor: Arog Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Study Start: 2016-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo	Matching placebo
Crenolanib Arm	Crenolanib	Investigational product (crenolanib)

Primary Outcome Measures

Name	Time	Method
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.	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (23)

Sarcoma Oncology Center; 🇺🇸 Santa Monica, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Duke Cancer Institute; 🇺🇸 Durham, North Carolina, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Leon Berard; 🇫🇷 Lyon, France

La Timone University Hospital; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire (CHU) de Reims; 🇫🇷 Reims, France

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