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Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02847429
Recruitment Status : Unknown
Verified January 2021 by Arog Pharmaceuticals, Inc..
Recruitment status was:  Active, not recruiting
First Posted : July 28, 2016
Last Update Posted : January 22, 2021
Centre Leon Berard
Fox Chase Cancer Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
GIST With D842V Mutated PDGFRA Gene Drug: Crenolanib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: Crenolanib Arm
Investigational product (crenolanib)
Drug: Crenolanib
Other Name: Crenolanib Besylate

Placebo Comparator: Placebo Arm
Matching placebo
Drug: Placebo

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02847429

Show Show 23 study locations
Sponsors and Collaborators
Arog Pharmaceuticals, Inc.
Centre Leon Berard
Fox Chase Cancer Center
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Principal Investigator: Jean-Yves Blay, MD Centre Leon Berard
Principal Investigator: Margaret von Mehren, MD Fox Chase Cancer Center
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Responsible Party: Arog Pharmaceuticals, Inc. Identifier: NCT02847429    
Other Study ID Numbers: ARO-012
2015-000287-34 ( EudraCT Number )
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Antineoplastic Agents