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

Primary Purpose

Gastrointestinal Stromal Tumors

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
imatinib mesylate
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring Gastrointestinal,, stromal,, neoadjuvant,, imatinib,, mesylate,, pre-operatory

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investivative site
  • Novartis Investivative site
  • Novartis Investivative site
  • Novartis Investivative site
  • Novartis Investivative site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

imatinib

Arm Description

Outcomes

Primary Outcome Measures

Objective response using the RECIST criteria

Secondary Outcome Measures

Progression free survival
Time and duration of response
Time to treatment failure
Overall survival

Full Information

First Posted
November 29, 2011
Last Updated
November 16, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01483014
Brief Title
Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
Acronym
CONVERT
Official Title
Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
Keywords
Gastrointestinal,, stromal,, neoadjuvant,, imatinib,, mesylate,, pre-operatory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
imatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Primary Outcome Measure Information:
Title
Objective response using the RECIST criteria
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
16 weeks
Title
Time and duration of response
Time Frame
16 weeks
Title
Time to treatment failure
Time Frame
16 weeks
Title
Overall survival
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30380-490
Country
Brazil
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Novartis Investigative Site
City
Florianopolis
State/Province
SC
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
01401-901
Country
Brazil
Facility Name
Novartis Investigative Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Novartis Investigative Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Novartis Investivative site
City
Belo Horizonte
Country
Brazil
Facility Name
Novartis Investivative site
City
Florianopolis
Country
Brazil
Facility Name
Novartis Investivative site
City
Porto Alegre
Country
Brazil
Facility Name
Novartis Investivative site
City
Rio de Janeiro
Country
Brazil
Facility Name
Novartis Investivative site
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://meetinglibrary.asco.org/content/140045-158
Description
Publication ISSN 0732183X

Learn more about this trial

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

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