Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
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1 other identifier
interventional
30
1 country
11
Brief Summary
This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of imatinib to convert a tumor from inoperable to operable.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2008
Typical duration for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 29, 2011
CompletedFirst Posted
Study publicly available on registry
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedNovember 18, 2016
November 1, 2016
3.6 years
November 29, 2011
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response using the RECIST criteria
16 weeks
Secondary Outcomes (4)
Progression free survival
16 weeks
Time and duration of response
16 weeks
Time to treatment failure
16 weeks
Overall survival
16 weeks
Study Arms (1)
imatinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- patients with age between 18 and 80 years
- diagnosis of GIST not previously treated
- Patients will be included in the protocol regardless of operability; in the case of an operable tumor, patients are eligible if, in the opinion of the surgeon, resection would be suboptimal, disfiguring or functionally disabling (i.e. incomplete resection or other which cold compromise severely the quality of life or other GI function)
You may not qualify if:
- presence of metastatic disease
- use of other antineoplastic treatment (chemotherapy, immunotherapy, radiotherapy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30380-490, Brazil
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil
Novartis Investigative Site
Florianópolis, Santa Catarina, 88034-000, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 01401-901, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 01509-900, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 05403-000, Brazil
Novartis Investivative site
Belo Horizonte, Brazil
Novartis Investivative site
Florianópolis, Brazil
Novartis Investivative site
Porto Alegre, Brazil
Novartis Investivative site
Rio de Janeiro, Brazil
Novartis Investivative site
São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2011
First Posted
December 1, 2011
Study Start
June 1, 2008
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
November 18, 2016
Record last verified: 2016-11