Back to resultsMasitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib
Primary Purpose
Gastro Intestinal Stromal Tumor
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
masitinib
sunitinib
Sponsored by
About this trial
This is an interventional treatment trial for Gastro Intestinal Stromal Tumor focused on measuring GIST, resistant, imatinib, gastro intestinal stromal tumor resistant to imatinib
Eligibility Criteria
Inclusion Criteria:
- Histological proven, metastatic, or locally advanced and non-operable GIST
- Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria
- C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available
- Patients resistant to imatinib at dose of 400 mg/day
Exclusion Criteria:
- 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
- Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
Sites / Locations
- Institute Gustave Roussy (IGR)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
masitinib
sunitinib
Arm Description
masitinib 12 mg/kg/day
sunitinib 50 mg/day
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
overall survival
From date of randomization until the date of death from any cause, assessed up to 36 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01506336
Brief Title
Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
April 2012 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Intestinal Stromal Tumor
Keywords
GIST, resistant, imatinib, gastro intestinal stromal tumor resistant to imatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
masitinib
Arm Type
Experimental
Arm Description
masitinib 12 mg/kg/day
Arm Title
sunitinib
Arm Type
Active Comparator
Arm Description
sunitinib 50 mg/day
Intervention Type
Drug
Intervention Name(s)
masitinib
Intervention Description
masitinib 12 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
sunitinib
Intervention Description
sunitinib 50 mg/day
Primary Outcome Measure Information:
Title
overall progression free survival
Description
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
Time Frame
up to 36 weeks
Secondary Outcome Measure Information:
Title
overall survival
Description
From date of randomization until the date of death from any cause, assessed up to 36 weeks
Time Frame
up to 36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological proven, metastatic, or locally advanced and non-operable GIST
Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria
C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available
Patients resistant to imatinib at dose of 400 mg/day
Exclusion Criteria:
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
Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Le Cesne, MD
Organizational Affiliation
Institut Gustave Roussy, Villejuif, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute Gustave Roussy (IGR)
City
Villejuif
ZIP/Postal Code
94815
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25122671
Citation
Adenis A, Blay JY, Bui-Nguyen B, Bouche O, Bertucci F, Isambert N, Bompas E, Chaigneau L, Domont J, Ray-Coquard I, Blesius A, Van Tine BA, Bulusu VR, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Le Cesne A. Masitinib in advanced gastrointestinal stromal tumor (GIST) after failure of imatinib: a randomized controlled open-label trial. Ann Oncol. 2014 Sep;25(9):1762-1769. doi: 10.1093/annonc/mdu237. Epub 2014 Jul 25.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4143095/
Description
Publication of clinical study results
Learn more about this trial
Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib
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