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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01483014
First received: November 29, 2011
Last updated: August 18, 2013
Last verified: August 2013
  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:


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: 30
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 01509-900
Novartis Investigative Site
São Paulo, SP, Brazil, 05403-000
Novartis Investigative Site
São Paulo, SP, Brazil, 01401-901
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: August 18, 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
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System 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 October 19, 2014