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Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

This study is currently recruiting participants.
Verified July 2017 by Arog Pharmaceuticals, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02847429
First Posted: July 28, 2016
Last Update Posted: July 25, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Centre Leon Berard
Fox Chase Cancer Center
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.
  Purpose
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 Intervention Phase
GIST With D842V Mutated PDGFRA Gene Drug: Crenolanib Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Arog Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: August 2016
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crenolanib Arm
Investigational product (crenolanib)
Drug: Crenolanib
Other Name: Crenolanib Besylate
Placebo Comparator: Placebo Arm
Matching placebo
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02847429


Contacts
Contact: Bradley Chiga 214-593-0550 bchiga@arogpharma.com
Contact: Information Contact info.012@davacro.com

  Show 30 Study Locations
Sponsors and Collaborators
Arog Pharmaceuticals, Inc.
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
  More Information

Responsible Party: Arog Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02847429     History of Changes
Other Study ID Numbers: ARO-012
First Submitted: July 21, 2016
First Posted: July 28, 2016
Last Update Posted: July 25, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Crenolanib
Antineoplastic Agents