Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST
NCT ID: NCT02847429
Last Updated: 2021-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2016-08-31
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Crenolanib Arm
Investigational product (crenolanib)
Crenolanib
Placebo Arm
Matching placebo
Placebo
Interventions
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Crenolanib
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Centre Leon Berard
OTHER
Fox Chase Cancer Center
OTHER
Arog Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Yves Blay, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Margaret von Mehren, MD
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Locations
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Sarcoma Oncology Center
Santa Monica, California, United States
University of Miami
Miami, Florida, United States
Duke Cancer Institute
Durham, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Institut Bergonie
Bordeaux, , France
Centre Leon Berard
Lyon, , France
La Timone University Hospital
Marseille, , France
Centre Hospitalier Universitaire (CHU) de Reims
Reims, , France
HELIOS Klinikum Berlin-Buch
Berlin, , Germany
Mannheim University Medical Centre, University of Heidelberg
Mannheim, , Germany
Universitätsklinikum München
Munich, , Germany
Policlinico S. Orsola-Malpighi
Bologna, , Italy
Istituto Nazionale Tumori
Milan, , Italy
Institut Regina Elena / IFO
Rome, , Italy
Candiolo Cancer Institute - FPO, IRCCS
Turin, , Italy
University Hospital The Norwegian Radium Hospital
Oslo, , Norway
M Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology
Warsaw, , Poland
Vall d'Hebron University Hospital
Barcelona, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Fundación Instituto Valenciano de Oncología
Valencia, , Spain
Countries
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Other Identifiers
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2015-000287-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ARO-012
Identifier Type: -
Identifier Source: org_study_id
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