Description:
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.
Title
- Brief Title: Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib
- Official Title: A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment
Clinical Trial IDs
- ORG STUDY ID:
AB11002
- NCT ID:
NCT01694277
Conditions
- Gastrointestinal Stromal Tumors
Interventions
Drug | Synonyms | Arms |
---|
Masitinib | AB1010 | Masitinib |
Sunitinib | Sutent | Sunitinib |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Masitinib | Experimental | Participants receive masitinib (12 mg/kg/day), given orally twice daily. | |
Sunitinib | Active Comparator | Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | From day of randomization to death, assessed for a maximum of 60 months |
Safety Issue: | |
Description: | 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 Outcome Measures
Measure: | Survival rate |
Time Frame: | Every 12 weeks until study completion, assessed for a maximum of 60 months |
Safety Issue: | |
Description: | 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. |
Measure: | Progression Free Survival (PFS) |
Time Frame: | From day of randomization to disease progression or death, assessed for a maximum of 60 months |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | AB Science |
Trial Keywords
- Gastrointestinal Stromal Tumour
- GIST
- non-resectable
- metastatic
- second line treatment
- resistance to imatinib
- tyrosine kinase inhibitor
Last Updated
December 8, 2020