Back to resultsMasitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib
Primary Purpose
Gastrointestinal Stromal Tumors
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Masitinib
Sunitinib
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring Gastrointestinal Stromal Tumour, GIST, non-resectable, metastatic, second line treatment, resistance to imatinib, tyrosine kinase inhibitor
Eligibility 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
Sites / Locations
- Washington University School of Medicine
- Institut Bergonié
- Hôpital l'Archet 2- Service de Cancérologie Digestive
- Istituto per la Ricerca e la Cura del Cancro (IRCC)
- Erasmus University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Masitinib
Sunitinib
Arm Description
Participants receive masitinib (12 mg/kg/day), given orally twice daily.
Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01694277
Brief Title
Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib
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 Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
Keywords
Gastrointestinal Stromal Tumour, GIST, non-resectable, metastatic, second line treatment, resistance to imatinib, tyrosine kinase inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
258 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Masitinib
Arm Type
Experimental
Arm Description
Participants receive masitinib (12 mg/kg/day), given orally twice daily.
Arm Title
Sunitinib
Arm Type
Active Comparator
Arm Description
Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally
Intervention Type
Drug
Intervention Name(s)
Masitinib
Other Intervention Name(s)
AB1010
Intervention Description
12 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
Sutent
Intervention Description
50 mg/day
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
From day of randomization to death, assessed for a maximum of 60 months
Secondary Outcome Measure Information:
Title
Survival rate
Description
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.
Time Frame
Every 12 weeks until study completion, assessed for a maximum of 60 months
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
From day of randomization to disease progression or death, assessed for a maximum of 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Le Cesne, M.D., Ph.D
Organizational Affiliation
Institute Gustave Roussy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital l'Archet 2- Service de Cancérologie Digestive
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Istituto per la Ricerca e la Cura del Cancro (IRCC)
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Facility Name
Erasmus University Medical Center
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib
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