Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Study Overview
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Brief Summary
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Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Detailed Description
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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.

Official Title
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A Prospective, Multicenter, Randomized, Open-label, Active-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Imatinib at 400 or 600 mg in Treatment of Patients With Gastro-intestinal Stromal Tumor in First Line Medical Treatment

Conditions
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Gastrointestinal Stromal Tumors

Intervention / Treatment
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* Drug: Masitinib
* Drug: Imatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Masitinib (7.5)<br>Participants receive masitinib (7.5 mg/kg/day), given orally twice daily. | Drug: Masitinib<br> <br> * Other names: AB1010;|
| Experimental: Masitinib (6.0)<br>Participants receive masitinib (6.0 mg/kg/day), given orally twice daily | Drug: Masitinib<br> <br> * Other names: AB1010;|
| Active Comparator: Active Comparator (7.5)<br>Participants receive imatinib at 400 or 600 mg per day | Drug: Imatinib<br>* imatinib 400 mg or 600 mg per day, per os<br>* Other names: Gleevec;|
| Active Comparator: Active Comparator (6.0)<br>Participants receive imatinib at 400 or 600 mg per day | Drug: Imatinib<br>* imatinib 400 mg or 600 mg per day, per os<br>* Other names: Gleevec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | 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). | From day of randomization to disease progression or death, assessed for a maximum of 96 months] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Overall survival is defined as time in months from the randomization date to the date of death due to any cause | From day of randomization to death, assessed for a maximum of 96 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastro-Intestinal Stromal Tumor, GIST, metastatic, non resectable locally advanced