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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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13 February 2023 |
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Main ID: |
NCT00812240 |
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Date of registration:
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19/12/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
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Scientific title:
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A Prospective, Multicenter, Randomized, Open-label, Active-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Imatinib at 400 or 600 mg in Treatment of Patients With Gastro-intestinal Stromal Tumor in First Line Medical Treatment |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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335 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00812240 |
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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 3
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Countries of recruitment
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France
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Lebanon
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United States
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Contacts
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Name:
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Antoine Adenis, 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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Centre Oscar Lambret, Lille, France |
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Key inclusion & exclusion criteria
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Main inclusion criteria include:
- Histologically proven, metastatic or locally advanced non resectable, or recurrent
post-surgery GIST
- Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who
relapsed after imatinib discontinuation
- c-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if
c-Kit negative
Main exclusion criteria include:
- Patient previously treated by tyrosine kinase inhibitors except imatinib in case of
inclusion criteria
- 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
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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Gastrointestinal Stromal Tumors
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Intervention(s)
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Drug: Imatinib
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Drug: Masitinib
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Primary Outcome(s)
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Progression Free Survival (PFS)
[Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 96 months]]
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Secondary Outcome(s)
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Overall Survival (OS)
[Time Frame: From day of randomization to death, assessed for a maximum of 96 months]
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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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