A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Sunitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib
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|ClinicalTrials.gov Identifier: NCT01694277|
Recruitment Status : Unknown
Verified August 2013 by AB Science.
Recruitment status was: Recruiting
First Posted : September 27, 2012
Last Update Posted : August 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumors||Drug: Masitinib Drug: Sunitinib||Phase 3|
GISTs are uncommon visceral sarcomas that arise predominantly in the gastrointestinal tract. Most GIST cells are positive for c-kit (CD117), a cell surface antigen corresponding to the Stem Cell Factor (SCF) receptor. The receptor has an intracellular tyrosine kinase (TK) joined by a juxtamembrane domain. It is hypothesized that all malignant GIST cells harbor a mutation of c-kit, resulting in the activation of c-kit and cell division and tumour growth.
Drugs that can selectively inhibit TKs are likely to be of benefit in GISTs. Masitinib (AB1010) is a TK inhibitor, selectively and effectively inhibiting c-kit. Imatinib is also a TK inhibitor indicated in the treatment of GIST. It might be associated with side effects and patients might develop a resistance to treatment over time. Based on pre-clinical and clinical studies, masitinib (AB1010) can be considered as a good candidate in the second line treatment of patients with GIST after progression with imatinib.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||December 2015|
masitinib at 12 mg/kg/day
Active Comparator: Sunitinib
sunitinib at 50 mg/day
- Overall Survival (OS) [ Time Frame: up to 24 weeks ]Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death
- Time to Progression [ Time Frame: up to 24 weeks ]Time to Progression from the date of randomization until disease progression
- Overall Progression Free Survival (PFS) [ Time Frame: up to 24 weeks ]From the date of randomization to disease progression or death
- Survival rate [ Time Frame: up to 24 weeks ]from the date of randomization until death
- Objective Response Rate [ Time Frame: up to 24 weeks ]Partial response or total Response
- Control Disease Rate [ Time Frame: up to 24 weeks ]Disease Control documented partial response (PR), complete response (CR) or stable disease (SD
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694277
|Contact: Axel Le Cesne, M.D., Ph.D.||+33 1 42 11 43 email@example.com|
|Bordeaux, France, 33000|