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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01506336 |
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Date of registration:
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03/01/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib
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Scientific title:
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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 |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01506336 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Axel Le Cesne, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Gustave Roussy, Villejuif, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Histological proven, metastatic, or locally advanced and non-operable GIST
2. Measurable tumor lesions with longest diameter = 20 mm using conventional techniques
or = 10 mm with spiral CT scan according RECIST criteria
3. C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation
of c-kit at any time if available
4. Patients resistant to imatinib at dose of 400 mg/day
Exclusion Criteria:
1. 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
2. Patient with active central nervous system (CNS) metastasis or with history of CNS
metastasis
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gastro Intestinal Stromal Tumor
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Intervention(s)
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Drug: sunitinib
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Drug: masitinib
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Primary Outcome(s)
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overall progression free survival
[Time Frame: up to 36 weeks]
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Secondary Outcome(s)
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overall survival
[Time Frame: up to 36 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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