Gastrointestinal Stromal Tumors
Conditions
Keywords
Gastro-Intestinal Stromal Tumor, GIST, metastatic, non resectable locally advanced
Brief summary
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
Detailed description
Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. In addition to its direct inhibitory action against these kinase targets, masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this prospective, multicenter, randomized, open-label, active-controlled study is to compare the efficacy and safety of masitinib with respect to imatinib in the first line treatment of gastro-intestinal stromal tumor (GIST). Treatment will be given until disease progression, limiting toxicity or patient consent withdrawal.
Interventions
DRUGMasitinib
DRUGImatinib
imatinib 400 mg or 600 mg per day, per os
Sponsors
AB Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main inclusion criteria include: * Histologically proven, metastatic or locally advanced non resectable, or recurrent post-surgery GIST * Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation * c-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-Kit negative Main
Exclusion criteria
include: * Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria * Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ * Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | From day of randomization to disease progression or death, assessed for a maximum of 96 months] | Progression Free Survival is defined as the time from randomization to first documentation of objective tumor progression (date of tumor assessment documenting progressive disease assessed by CT Scan according to RECIST 1.1 and based on central review) or to death due to any cause (whichever comes first). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From day of randomization to death, assessed for a maximum of 96 months | Overall survival is defined as time in months from the randomization date to the date of death due to any cause |
Countries
France, Lebanon, United States
Outcome results
None listed