Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

• ClinicalTrials.gov Identifier: NCT02847429
• Recruitment Status: Unknown
• First Posted: July 28, 2016
• Last Update Posted: January 22, 2021
• Sponsor: Arog Pharmaceuticals, Inc.
• Collaborators: Centre Leon Berard; Fox Chase Cancer Center
• Information provided by (Responsible Party): Arog Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: July 21, 2016
• First Posted Date: July 28, 2016
• Last Update Posted Date: January 22, 2021
• Study Start Date: August 2016
• Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 25, 2016): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: July 25, 2016): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: GIST With D842V Mutated PDGFRA Gene

Intervention

• Drug: Crenolanib
  Other Name: Crenolanib Besylate
• Drug: Placebo

Study Arms

• Experimental: Crenolanib Arm
  Investigational product (crenolanib)
  Intervention: Drug: Crenolanib
• Placebo Comparator: Placebo Arm
  Matching placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 25, 2016): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2021
• Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Italy, Norway, Poland, Spain, United States
• Removed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02847429
• Other Study ID Numbers: ARO-012; 2015-000287-34 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Arog Pharmaceuticals, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Arog Pharmaceuticals, Inc.
• Original Study Sponsor: Same as current

Collaborators

• Centre Leon Berard
• Fox Chase Cancer Center

Investigators

• Principal Investigator: Jean-Yves Blay, MD; Centre Leon Berard
• Principal Investigator: Margaret von Mehren, MD; Fox Chase Cancer Center

• PRS Account: Arog Pharmaceuticals, Inc.
• Verification Date: January 2021