A phase II study to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib

A phase II study to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib

Gastrointestinal Stromal Tumor

Unknown

2

Start Date 01/19/2011

Age of Trial (yrs) 13.3

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

AB Science

AB Science, Paris clinical@ab-science.com +33 (0)1 47 20 00 14

Randomized

Oral

Masitinib is also being developed for patients resistant to imatinib (Glivec(r))
in an on-going phase 2 study, which is comparing masitinib to the approved
second line drug, sunitinib (Sutent(r)). Results reported in a press release in Feb, 2012 showed that masitinib significantly extends overall survival compared to Sutent, however questions remain about whether treatment received (or not received) after the trial could have caused the survival difference. At the time of the press release, there was no difference in the time it took for patients to progression on masitinib compared to Sutent.
Key variables to be assessed include overall survival and PFS.

Characteristics of the phase 2 in Second line treatment of GIST

A prospective, multicenter, randomized, open-label, active-controlled,
2-parallel group, phase II study to compare efficacy and safety of masitinib
at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with
gastro-intestinal stromal tumor resistant to imatinib

Patients will be randomized in two groups:
* Group 1: Patients will receive masitinib at 12 mg/kg/day
* Group 2: Patients will receive sunitinib at 50 mg/day

The primary criterion will be the Overall Progression Free Survival (PFS),
defined as the delay between the date of randomisation to the date of
documented progression or any cause of death during the study. Overall Survival
will be the main secondary criterion.