Trial record 19 of 164 for:
"Gastrointestinal Stromal Tumors"
Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST) (CONVERT)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01483014
First received: November 29, 2011
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumors |
Drug: imatinib mesylate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST) |
Resource links provided by NLM:
Genetics Home Reference related topics:
gastrointestinal stromal tumor
MedlinePlus related topics:
Cancer
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Objective response using the RECIST criteria [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression free survival [ Designated as safety issue: No ]
- Time and duration of response [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Enrollment: | 39 |
| Study Start Date: | June 2008 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: imatinib | Drug: imatinib mesylate |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion criteria:
- presence of metastatic disease
- use of other antineoplastic treatment (chemotherapy, immunotherapy, radiotherapy)
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483014
Locations
| Brazil | |
| Novartis Investigative Site | |
| Belo Horizonte, MG, Brazil, 30380-490 | |
| Novartis Investigative Site | |
| Rio de Janeiro, RJ, Brazil, 20230-130 | |
| Novartis Investigative Site | |
| Florianopolis, SC, Brazil, 88034-000 | |
| Novartis Investigative Site | |
| São Paulo, SP, Brazil, 01401-901 | |
| Novartis Investigative Site | |
| São Paulo, SP, Brazil, 05403-000 | |
| Novartis Investigative Site | |
| São Paulo, SP, Brazil, 01509-900 | |
| Novartis Investivative site | |
| Belo Horizonte, Brazil | |
| Novartis Investivative site | |
| Florianopolis, Brazil | |
| Novartis Investivative site | |
| Porto Alegre, Brazil | |
| Novartis Investivative site | |
| Rio de Janeiro, Brazil | |
| Novartis Investivative site | |
| Sao Paulo, Brazil | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01483014 History of Changes |
| Other Study ID Numbers: | CSTI571BBR10 |
| Study First Received: | November 29, 2011 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration Brazil: Ministry of Health |
Keywords provided by Novartis:
|
Gastrointestinal, stromal, neoadjuvant, |
imatinib, mesylate, pre-operatory |
Additional relevant MeSH terms:
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013