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Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

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ClinicalTrials.gov Identifier: NCT02847429
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : March 16, 2018
Sponsor:
Collaborators:
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

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 2019
Estimated Study Completion Date : August 2019


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 ]


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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

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

Locations
United States, California
Sarcoma Oncology Center Recruiting
Santa Monica, California, United States, 90403
Contact: Sant K Chawla, MD       santchawla@aol.com   
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Trent C Jonathan, MD       jtrent@med.miami.edu   
United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Richard F Riedel, MD       richard.riedel@duke.edu   
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Michael C Heinrich, MD       heinrich@ohsu.edu   
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Margaret von Mehren, MD       Margaret.vonMehren@fccc.edu   
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Neeta Somaiah, MD       NSomaiah@mdanderson.org   
France
Institut Bergonie Recruiting
Bordeaux, France
Contact: Antoine Italiano       a.italiano@bordeaux.unicancer.fr   
Centre Leon Berard Recruiting
Lyon, France, 69008
Contact: Jean-Yves Blay, MD       jean-yves.blay@lyon.unicancer.fr   
La Timone University Hospital Recruiting
Marseille, France
Contact: Florence Duffaud       fduffaud@mail.ap-hm.fr   
Centre Hospitalier Universitaire (CHU) de Reims Recruiting
Reims, France
Contact: Olivier Bouche       obouche@chu-reims.fr   
Germany
HELIOS Klinikum Berlin-Buch Recruiting
Berlin, Germany
Contact: Peter Reichardt       peter.reichardt@helios-kliniken.de   
Mannheim University Medical Centre, University of Heidelberg Recruiting
Mannheim, Germany, 68167
Contact: Peter Hohenberger, MD       peter.hohenberger@umm.de   
Universitätsklinikum München Recruiting
Munich, Germany
Contact: Lars Lindner       Lars.Lindner@med.uni-muenchen.de   
Italy
Policlinico S. Orsola-Malpighi Recruiting
Bologna, Italy
Contact: Maria Pantaleo       maria.pantaleo@unibo.it   
Istituto Nazionale Tumori Recruiting
Milan, Italy, 20133
Contact: Elena Fumagalli, MD       Elena.Fumagalli@istitutotumori.mi.it   
Institut Regina Elena / IFO Recruiting
Rome, Italy
Contact: Virginia Ferraresi       ferraresi@ifo.it   
Candiolo Cancer Institute - FPO, IRCCS Recruiting
Turin, Italy
Contact: Giovanni Grignani       giovanni.grignani@ircc.it   
Norway
University Hospital The Norwegian Radium Hospital Recruiting
Oslo, Norway
Contact: Kirsten S Hall, MD       KSH@ous-hf.no   
Poland
M Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology Recruiting
Warsaw, Poland
Contact: Piotr Rutkowski, MD       rutkowskip@coi.waw.pl   
Spain
Vall d'Hebron University Hospital Recruiting
Barcelona, Spain
Contact: Cesar Serrano, MD       cserrano@vhio.net   
Hospital Universitario Puerta de Hierro Recruiting
Madrid, Spain
Contact: Ricardo Cubedo       rcubedo@gmail.com   
Hospital Virgen del Rocio Recruiting
Sevilla, Spain
Contact: Javier Martin       jmartin@mustbesevilla.org   
Fundación Instituto Valenciano de Oncología Recruiting
Valencia, Spain
Contact: Javier Lavernia       acog@fivo.org   
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

Responsible Party: Arog Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02847429     History of Changes
Other Study ID Numbers: ARO-012
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018

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