Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

• ClinicalTrials.gov Identifier: NCT01694277
• Recruitment Status: Completed
• First Posted: September 27, 2012
• Last Update Posted: December 8, 2020
• Sponsor: AB Science
• Information provided by (Responsible Party): AB Science

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Gastrointestinal Stromal Tumors	Drug: Masitinib; Drug: Sunitinib	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 258 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: April 2012
• Actual Primary Completion Date: December 2020
• Actual Study Completion Date: December 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Masitinib; Participants receive masitinib (12 mg/kg/day), given orally twice daily.	Drug: Masitinib; 12 mg/kg/day; Other Name: 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 Name: Sutent

Outcome Measures

Primary Outcome Measures :

1. Overall Survival (OS) [ Time Frame: From day of randomization to death, assessed for a maximum of 60 months ]
   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.

Secondary Outcome Measures :

1. Survival rate [ Time Frame: Every 12 weeks until study completion, assessed for a maximum of 60 months ]
   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.
2. Progression Free Survival (PFS) [ Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months ]
   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

France

Institut Bergonié

Bordeaux, France, 33000

Hôpital l'Archet 2- Service de Cancérologie Digestive

Nice, France, 06202

Italy

Istituto per la Ricerca e la Cura del Cancro (IRCC)

Candiolo, Italy, 10060

Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands, 3015 GD

Sponsors and Collaborators

AB Science

Investigators

• Principal Investigator: Axel Le Cesne, M.D., Ph.D; Institute Gustave Roussy

More Information

• Responsible Party: AB Science
• ClinicalTrials.gov Identifier: NCT01694277
• Other Study ID Numbers: AB11002
• First Posted: September 27, 2012
• Last Update Posted: December 8, 2020
• Last Verified: December 2020

Keywords provided by AB Science:

Gastrointestinal Stromal Tumour; GIST; non-resectable; metastatic; second line treatment; resistance to imatinib; tyrosine kinase inhibitor

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors; Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Sunitinib; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action