Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib

Gastro Intestinal Stromal Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506336
• Other study ID #: AB07001
• Status: Completed
• Phase: Phase 2
• Start date: October 2008
• Est. completion date: April 2012

Study information

• Verified date: December 2018
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastro Intestinal Stromal Tumor
• Gastrointestinal Stromal Tumors

Intervention

Drug:
• masitinib
masitinib 12 mg/kg/day
• sunitinib
sunitinib 50 mg/day

Locations

Country	Name	City	State
France	Institute Gustave Roussy (IGR)	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Country where clinical trial is conducted

France, 

References & Publications (1)

Adenis A, Blay JY, Bui-Nguyen B, Bouché O, Bertucci F, Isambert N, Bompas E, Chaigneau L, Domont J, Ray-Coquard I, Blésius A, Van Tine BA, Bulusu VR, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Le Cesne A. Masitinib in advanced gastrointestinal — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	overall survival	From date of randomization until the date of death from any cause, assessed up to 36 weeks	up to 36 weeks

External Links

•   Publication of clinical study results