GIST With D842V Mutated PDGFRA Gene Clinical Trial
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
| Verified date | January 2021 |
| Source | Arog Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 120 |
| Est. completion date | August 2021 |
| Est. primary completion date | August 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Institut Bergonie | Bordeaux | |
| France | Centre Leon Berard | Lyon | |
| France | La Timone University Hospital | Marseille | |
| France | Centre Hospitalier Universitaire (CHU) de Reims | Reims | |
| Germany | HELIOS Klinikum Berlin-Buch | Berlin | |
| Germany | Mannheim University Medical Centre, University of Heidelberg | Mannheim | |
| Germany | Universitätsklinikum München | Munich | |
| Italy | Policlinico S. Orsola-Malpighi | Bologna | |
| Italy | Istituto Nazionale Tumori | Milan | |
| Italy | Institut Regina Elena / IFO | Rome | |
| Italy | Candiolo Cancer Institute - FPO, IRCCS | Turin | |
| Norway | University Hospital The Norwegian Radium Hospital | Oslo | |
| Poland | M Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology | Warsaw | |
| Spain | Vall d'Hebron University Hospital | Barcelona | |
| Spain | Hospital Universitario Puerta de Hierro | Madrid | |
| Spain | Hospital Virgen del Rocio | Sevilla | |
| Spain | Fundación Instituto Valenciano de Oncología | Valencia | |
| United States | Duke Cancer Institute | Durham | North Carolina |
| United States | MD Anderson Cancer Center | Houston | Texas |
| United States | University of Miami | Miami | Florida |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Sarcoma Oncology Center | Santa Monica | California |
| Lead Sponsor | Collaborator |
|---|---|
| Arog Pharmaceuticals, Inc. | Centre Leon Berard, Fox Chase Cancer Center |
United States, France, Germany, Italy, Norway, Poland, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |