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Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST) (CONVERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01483014
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: imatinib mesylate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
Study Start Date : June 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012


Arm Intervention/treatment
Experimental: imatinib Drug: imatinib mesylate



Primary Outcome Measures :
  1. Objective response using the RECIST criteria [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 16 weeks ]
  2. Time and duration of response [ Time Frame: 16 weeks ]
  3. Time to treatment failure [ Time Frame: 16 weeks ]
  4. Overall survival [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483014


Locations
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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, 01509-900
Novartis Investigative Site
São Paulo, SP, Brazil, 05403-000
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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01483014    
Other Study ID Numbers: CSTI571BBR10
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Gastrointestinal,
stromal,
neoadjuvant,
imatinib,
mesylate,
pre-operatory
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action