Gastrointestinal Stromal Tumors
Conditions
Keywords
Gastrointestinal Stromal Tumour, GIST, non-resectable, metastatic, second line treatment, resistance to imatinib, tyrosine kinase inhibitor
Brief summary
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.
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. 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).
Interventions
DRUGMasitinib
12 mg/kg/day
DRUGSunitinib
50 mg/day
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: * Patient with histological proven metastatic GIST or non-operable locally advanced GIST * Patient with c-Kit (CD117) positive tumor detected immuno-histochemically * Patient after at least one progression with imatinib at a dose up to 800mg. Progression is defined as a RECIST 1.1 and/or CHOI disease progression while receiving imatinib treatment. Main
Exclusion criteria
include: * 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 * Pregnant, or nursing female patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From day of randomization to death, assessed for a maximum of 60 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | Every 12 weeks until study completion, assessed for a maximum of 60 months | 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. |
| Progression Free Survival (PFS) | From day of randomization to disease progression or death, assessed for a maximum of 60 months | 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. |
Countries
France, Italy, Netherlands, United States
Outcome results
None listed