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Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

Sponsor
Arog Pharmaceuticals, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02847429
Collaborator
Centre Leon Berard (Other), Fox Chase Cancer Center (Other)
120
Enrollment
23
Locations
2
Arms
60
Duration (Months)
5.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2016
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Crenolanib Arm

Investigational product (crenolanib)

Drug: Crenolanib
Other Names:
  • Crenolanib Besylate

    		•
    Placebo Comparator: Placebo Arm

    Matching placebo

    Drug: Placebo

    Outcome Measures

    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. [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. [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    1. Subjects (male or female) ≥ 18 years of age

    2. Female subjects with reproductive potential must have negative serum or urine pregnancy test

    3. 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

    Locations

    Site City State Country Postal Code
    1 Sarcoma Oncology Center Santa Monica California United States 90403
    2 University of Miami Miami Florida United States 33136
    3 Duke Cancer Institute Durham North Carolina United States 27710
    4 Oregon Health and Science University Portland Oregon United States 97239
    5 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    6 MD Anderson Cancer Center Houston Texas United States 77030
    7 Institut Bergonie Bordeaux France
    8 Centre Leon Berard Lyon France 69008
    9 La Timone University Hospital Marseille France
    10 Centre Hospitalier Universitaire (CHU) de Reims Reims France
    11 HELIOS Klinikum Berlin-Buch Berlin Germany
    12 Mannheim University Medical Centre, University of Heidelberg Mannheim Germany 68167
    13 Universitätsklinikum München Munich Germany
    14 Policlinico S. Orsola-Malpighi Bologna Italy
    15 Istituto Nazionale Tumori Milan Italy 20133
    16 Institut Regina Elena / IFO Rome Italy
    17 Candiolo Cancer Institute - FPO, IRCCS Turin Italy
    18 University Hospital The Norwegian Radium Hospital Oslo Norway
    19 M Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology Warsaw Poland
    20 Vall d'Hebron University Hospital Barcelona Spain
    21 Hospital Universitario Puerta de Hierro Madrid Spain
    22 Hospital Virgen del Rocio Sevilla Spain
    23 Fundación Instituto Valenciano de Oncología Valencia Spain

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arog Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02847429
    Other Study ID Numbers:
    • ARO-012
    • 2015-000287-34
    First Posted:
    Jul 28, 2016
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Jan 1, 2021
    Additional relevant MeSH terms:
    Crenolanib

    Study Results

    No Results Posted as of Jan 22, 2021