Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib
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
1 other identifier
interventional
44
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 3, 2012
CompletedFirst Posted
Study publicly available on registry
January 10, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedDecember 11, 2018
December 1, 2018
2.9 years
January 3, 2012
December 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall progression free survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
up to 36 weeks
Secondary Outcomes (1)
overall survival
up to 36 weeks
Study Arms (2)
masitinib
EXPERIMENTALmasitinib 12 mg/kg/day
sunitinib
ACTIVE COMPARATORsunitinib 50 mg/day
Interventions
Eligibility Criteria
You may qualify if:
- Histological proven, metastatic, or locally advanced and non-operable GIST
- Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria
- C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available
- Patients resistant to imatinib at dose of 400 mg/day
You may not qualify if:
- 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
- Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AB Sciencelead
Study Sites (1)
Institute Gustave Roussy (IGR)
Villejuif, 94815, France
Related Publications (1)
Adenis A, Blay JY, Bui-Nguyen B, Bouche O, Bertucci F, Isambert N, Bompas E, Chaigneau L, Domont J, Ray-Coquard I, Blesius A, Van Tine BA, Bulusu VR, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Le Cesne A. Masitinib in advanced gastrointestinal stromal tumor (GIST) after failure of imatinib: a randomized controlled open-label trial. Ann Oncol. 2014 Sep;25(9):1762-1769. doi: 10.1093/annonc/mdu237. Epub 2014 Jul 25.
PMID: 25122671RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Axel Le Cesne, MD
Institut Gustave Roussy, Villejuif, France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2012
First Posted
January 10, 2012
Study Start
October 1, 2008
Primary Completion
September 1, 2011
Study Completion
April 1, 2012
Last Updated
December 11, 2018
Record last verified: 2018-12