Date: 2015-07-21
Type of information: DSMB assessment
phase: 3
Announcement: DSMB assessment
Company: AB Science (France)
Product: masitinib
Action
mechanism: kinase inhibitor/tyrosine kinase inhibitor
Disease: non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxtamembrane domain of c-Kit
Therapeutic area: Cancer - Oncology
Country:
Trial
details: This international, randomised, open-label, phase 3 study will compare the efficacy and safety of masitinib at 7.5 mg/kg/day to dacarbazine in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxtamembrane domain of c-Kit. The trial will enrol approximately 200 patients, across 80 centres around the world, randomised equally between the masitinib and dacarbazine treatment arms.
Latest
news: * On July 21,2015, AB Science announced the successful non futility analysis related to the masitinib phase 3 trial in metastatic melanoma, carrying a mutation in the juxta membrane domain of c-Kit. Based on these results, the Independent Data Safety Monitoring Committee (IDMC) has recommended continuation of the study. The ongoing phase 3 trial (AB08026) is an open-label, controlled study comparing masitinib to dacarbazine and designed to assess the safety and efficacy of masitinib in patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta-membrane (JM) domain of c-Kit.
Masitinib is an inhibitor of this c-Kit mutation and blocks its activity at nanomolar concentration.
The study’s primary measure of efficacy is objective response rate. Secondary efficacy measures include progression-free survival and overall survival. The statistical hypothesis is based on detecting a response rate of about 40% with masitinib and 15% with dacarbazine. The study plans to enroll 120 patients.
This study was assessed as non-futile by the IDMC. The characteristics of the futility test were as follows:
- Performed after more than one-third of the planned study population had reached the time-point to assess efficacy.
- Hypothesis that all remaining patients to be enrolled in the study will follow the trend observed in patients already enrolled at the time of futility analysis.
- P-value below 5%.
- Conditional power (predictive probability of success) of 20%.
The next step for this study is an interim analysis, expected once two-thirds of the planned study population had reached the time-point to assess efficacy.
