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

November 16, 2016 updated by: Novartis Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • 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
        • Novartis Investivative site
    • MG
      • Belo Horizonte, MG, Brazil, 30380-490
        • Novartis Investigative Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20230-130
        • Novartis Investigative Site
    • SC
      • Florianopolis, SC, Brazil, 88034-000
        • Novartis Investigative Site
    • SP
      • São Paulo, SP, Brazil, 05403-000
        • Novartis Investigative Site
      • São Paulo, SP, Brazil, 01509-900
        • Novartis Investigative Site
      • São Paulo, SP, Brazil, 01401-901
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: imatinib
Drug: imatinib mesylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response using the RECIST criteria
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 16 weeks
16 weeks
Time and duration of response
Time Frame: 16 weeks
16 weeks
Time to treatment failure
Time Frame: 16 weeks
16 weeks
Overall survival
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 29, 2011

First Submitted That Met QC Criteria

November 30, 2011

First Posted (Estimate)

December 1, 2011

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSTI571BBR10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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