Clinical Trial: 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

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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 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.


Sponsor: AB Science

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: AB Science

Dates:
Date Received: August 22, 2012
Date Started: April 2012
Date Completion: December 2015
Last Updated: August 13, 2013
Last Verified: August 2013