Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:6/22/2018
Start Date:August 2016
End Date:August 2019
Contact:Bradley Chiga
Email:bchiga@arogpharma.com
Phone:214-593-0550

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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

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.


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
We found this trial at
7
sites
Houston, Texas 77030
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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229 Cours de l'Argonne
Bordeaux, 33000
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Bordeaux,
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20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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Durham, NC
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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Santa Monica, California 90403
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Santa Monica, CA
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