Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Phase 3

Terminated

• Conditions: Gastrointestinal Stromal Tumors
• Interventions: Drug: Imatinib; Drug: Masitinib

• Registration Number: NCT00812240
• Lead Sponsor: AB Science

Brief Summary

Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Detailed Description

Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. In addition to its direct inhibitory action against these kinase targets, masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this prospective, multicenter, randomized, open-label, active-controlled study is to compare the efficacy and safety of masitinib with respect to imatinib in the first line treatment of gastro-intestinal stromal tumor (GIST). Treatment will be given until disease progression, limiting toxicity or patient consent withdrawal.

Study Timeline

• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Study Start: 2009-01
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Disposition First Submitted: 2019-11-28
• Disposition First Submitted QC: 2019-11-28
• Status Verified: 2019-12
• Disposition First Posted: 2019-12-02
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator (7.5)	Imatinib	Participants receive imatinib at 400 or 600 mg per day
Masitinib (7.5)	Masitinib	Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.
Masitinib (6.0)	Masitinib	Participants receive masitinib (6.0 mg/kg/day), given orally twice daily
Active Comparator (6.0)	Imatinib	Participants receive imatinib at 400 or 600 mg per day

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	From day of randomization to disease progression or death, assessed for a maximum of 96 months]	Progression Free Survival is defined as the time from randomization to first documentation of objective tumor progression (date of tumor assessment documenting progressive disease assessed by CT Scan according to RECIST 1.1 and based on central review) or to death due to any cause (whichever comes first).

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From day of randomization to death, assessed for a maximum of 96 months	Overall survival is defined as time in months from the randomization date to the date of death due to any cause

Trial Locations

Locations (41)

MD Anderson Cancer Center; 🇺🇸 Orlando, Florida, United States

The Emory Clinic; 🇺🇸 Atlanta, Georgia, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Beth Israel Medical Center; 🇺🇸 New York, New York, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Cancer Centers of the Carolinas; 🇺🇸 Greenville, South Carolina, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Centre Hospitalier d'Abbeville; 🇫🇷 Abbeville, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Hôpital Jean Minjoz; 🇫🇷 Besançon, France

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