Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST) (NCT00812240) | Clinical Trial Compass
TerminatedPhase 3
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
Stopped: Sponsor decision based on portfolio prioritization
United States335 participantsStarted 2009-01
Plain-language summary
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main inclusion criteria include:
* Histologically proven, metastatic or locally advanced non resectable, or recurrent post-surgery GIST
* Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
* c-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-Kit negative
Main exclusion criteria include:
* Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria
* Patient treated for a cancer other than GIST 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
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: From day of randomization to disease progression or death, assessed for a maximum of 96 months]