TRIAL DETAIL

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

Drug:
Trial Name:
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
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Unknown
Phase:
2
Start Date 01/19/2011
Age of Trial (yrs) 11.4
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
Sponsor:
AB Science
Patient Contact:
AB Science, Paris clinical@ab-science.com +33 (0)1 47 20 00 14
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
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.

Trial Links

 
 
 
 

Trial Results

 
 

Drug Information

AB Science website
 
Comparative Toxicogenomics Database
 
Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial
 
Masitinib Phase II Trial Reports Benefit in New GISTs
 
Masitinib, (AB1010), a potent and selective TKI of targeting KIT (PDF)
 
Press Release - Masitinib extends overall survival in randomized phase II trial for GIST vs. Sutent for second line treatment
 
Oral tyrosine kinase inhibitor masitinib in combination with gemcitabine in patients with advanced pancreatic cancer: A multicenter phase II study.
 
AB Science reports phase 3 study results of masitinib in combination with Gemzar® for treatment of pancreatic cancer. Read more: AB Science reports phase 3 study results of masitinib in combination with Gemzar® for treatment of pancreatic cancer. - FiercePharma http://www.fiercepharma.com/press-releases/ab-science-reports-phase-3-study-results-masitinib-combination-gemzar-treat#ixzz2AsvsdSb7 Subscribe: http://www.fiercepharma.com/signup?sourceform=Viral-Tynt-FiercePharma-FiercePharma
 
AB Science announces a voluntary hold in the clinical studies of Masitinib worldwide (Jun, 2021).
 

Trial Sites

Name
Address
City
State
Zip
Country
Villejuif
Val de Narne
94805
France
Marseille
13000
France
Lille
Nord
59020
France