A Phase 3 interventional study of Masitinib and Sunitinib in Gastrointestinal Stromal Tumors, sponsored by AB Science. Completed at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-08.
Sponsored by AB Science · Phase 3, Interventional, and Treatment
The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib.
Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day with respect to sunitinib at 50 mg/day in the treatment of imatinib-resistant gastro-intestinal stromal tumor (GIST).
333 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 61 are open to participants now.
This study's enrollment of 258 is above the median of 50 across 243 interventional studies indexed under Gastrointestinal Stromal Tumors.
Browse Gastrointestinal Stromal Tumors studies →AB Science is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main inclusion criteria include:
Main exclusion criteria include:
Participants receive masitinib (12 mg/kg/day), given orally twice daily.
Drug: Masitinib
Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally
Drug: Sunitinib
12 mg/kg/day
Also known as: AB1010
50 mg/day
Also known as: Sutent
Overall Survival (OS)
Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.
Time frame: From day of randomization to death, assessed for a maximum of 60 months
Survival rate
Survival rate is defined as the number of patients alive divided by the number of patients in the population of analysis. Assessed at week-8, -16, -24, and every 12 weeks thereafter.
Time frame: Every 12 weeks until study completion, assessed for a maximum of 60 months
Progression Free Survival (PFS)
Progression Free Survival is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed by the investigator on CT scan according to RECIST 1.1 criteria and/or CHOI criteria.
Time frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Gastrointestinal Stromal Tumors→
AB Science