Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694277
• Other study ID #: AB11002
• Status: Completed
• Phase: Phase 3
• Start date: April 2012
• Est. completion date: December 2020

Study information

• Verified date: December 2020
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib.

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. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day with respect to sunitinib at 50 mg/day in the treatment of imatinib-resistant gastro-intestinal stromal tumor (GIST).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main inclusion criteria include:

• Patient with histological proven metastatic GIST or non-operable locally advanced GIST

• Patient with c-Kit (CD117) positive tumor detected immuno-histochemically

• Patient after at least one progression with imatinib at a dose up to 800mg. Progression is defined as a RECIST 1.1 and/or CHOI disease progression while receiving imatinib treatment.

Main exclusion criteria include:

• 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

• Pregnant, or nursing female patient

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Masitinib
12 mg/kg/day
• Sunitinib
50 mg/day

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux
France	Hôpital l'Archet 2- Service de Cancérologie Digestive	Nice
Italy	Istituto per la Ricerca e la Cura del Cancro (IRCC)	Candiolo
Netherlands	Erasmus University Medical Center	Rotterdam
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

United States,  France,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.	From day of randomization to death, assessed for a maximum of 60 months
Secondary	Survival rate	Survival rate is defined as the number of patients alive divided by the number of patients in the population of analysis. Assessed at week-8, -16, -24, and every 12 weeks thereafter.	Every 12 weeks until study completion, assessed for a maximum of 60 months
Secondary	Progression Free Survival (PFS)	Progression Free Survival is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed by the investigator on CT scan according to RECIST 1.1 criteria and/or CHOI criteria.	From day of randomization to disease progression or death, assessed for a maximum of 60 months