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Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

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ClinicalTrials.gov Identifier: NCT02847429
Recruitment Status : Active, not recruiting
First Posted : July 28, 2016
Last Update Posted : January 22, 2021
Sponsor:
Collaborators:
Centre Leon Berard
Fox Chase Cancer Center
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE July 21, 2016
First Posted Date  ICMJE July 28, 2016
Last Update Posted Date January 22, 2021
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE GIST With D842V Mutated PDGFRA Gene
Intervention  ICMJE
  • Drug: Crenolanib
    Other Name: Crenolanib Besylate
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Crenolanib Arm
    Investigational product (crenolanib)
    Intervention: Drug: Crenolanib
  • Placebo Comparator: Placebo Arm
    Matching placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Italy,   Norway,   Poland,   Spain,   United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT02847429
Other Study ID Numbers  ICMJE ARO-012
2015-000287-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arog Pharmaceuticals, Inc.
Study Sponsor  ICMJE Arog Pharmaceuticals, Inc.
Collaborators  ICMJE
  • Centre Leon Berard
  • Fox Chase Cancer Center
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP