Overview

This trial is active, not recruiting.

Condition gastro intestinal stromal tumor
Treatments masitinib, sunitinib
Phase phase 2
Targets VEGF, FLT-3, KIT, PDGF
Sponsor AB Science
Start date October 2008
End date September 2011
Trial size 44 participants
Trial identifier NCT01506336, AB07001

Summary

The objective is 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
masitinib 12 mg/kg/day
masitinib
masitinib 12 mg/kg/day
(Active Comparator)
sunitinib 50 mg/day
sunitinib
sunitinib 50 mg/day

Primary Outcomes

Measure
overall progression free survival
time frame: up to 36 weeks

Secondary Outcomes

Measure
overall survival
time frame: up to 36 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Histological proven, metastatic, or locally advanced and non-operable GIST 2. Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria 3. C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available 4. Patients resistant to imatinib at dose of 400 mg/day Exclusion Criteria: 1. Patient treated for a cancer other than GIST cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ 2. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by AB Science.