Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Stromal Tumors
• Intervention / Treatment: Drug: Masitinib; Drug: Sunitinib

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. 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).

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Institut Bergonié
  • Nice, France, 06202
    • Hôpital l'Archet 2- Service de Cancérologie Digestive
• Italy
  • Candiolo, Italy, 10060
    • Istituto per la Ricerca e la Cura del Cancro (IRCC)
• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus University Medical Center
• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Masitinib; Participants receive masitinib (12 mg/kg/day), given orally twice daily.	Drug: Masitinib; 12 mg/kg/day; Other Names: AB1010
Active Comparator: Sunitinib; Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally	Drug: Sunitinib; 50 mg/day; Other Names: Sutent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: AB Science
• Investigators: Principal Investigator: Axel Le Cesne, M.D., Ph.D, Institute Gustave Roussy

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: August 22, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: tyrosine kinase inhibitor; metastatic; GIST; non-resectable; second line treatment; Gastrointestinal Stromal Tumour; resistance to imatinib
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Gastrointestinal Stromal Tumors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: AB11002