Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST
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| ClinicalTrials.gov Identifier: NCT02847429 |
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Recruitment Status : Unknown
Verified January 2021 by Arog Pharmaceuticals, Inc..
Recruitment status was: Active, not recruiting
First Posted : July 28, 2016
Last Update Posted : January 22, 2021
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Sponsor:
Arog Pharmaceuticals, Inc.
Collaborators:
Centre Leon Berard
Fox Chase Cancer Center
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.
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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 2021 |
| Estimated Study Completion Date : | August 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Gastrointestinal stromal tumor
MedlinePlus related topics:
Genes and Gene Therapy
| Arm | Intervention/treatment |
|---|---|
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Experimental: Crenolanib Arm
Investigational product (crenolanib)
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Drug: Crenolanib
Other Name: Crenolanib Besylate |
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Placebo Comparator: Placebo Arm
Matching placebo
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Drug: Placebo |
Primary Outcome Measures :
- 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 :
- 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, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing
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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
- Subjects (male or female) ≥ 18 years of age
- Female subjects with reproductive potential must have negative serum or urine pregnancy test
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Exclusion Criteria:
- Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis)
- Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Female subject who is pregnant or breastfeeding, or planning to become pregnant within 30 days after ending treatment
- 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
Locations
Show 23 study locations
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 |
| Other Study ID Numbers: |
ARO-012 2015-000287-34 ( EudraCT Number ) |
| First Posted: | July 28, 2016 Key Record Dates |
| Last Update Posted: | January 22, 2021 |
| Last Verified: | January 2021 |
Additional relevant MeSH terms:
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Crenolanib Antineoplastic Agents |