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Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171977
First received: September 13, 2005
Last updated: August 6, 2012
Last verified: August 2012

September 13, 2005
August 6, 2012
July 2004
April 2009   (final data collection date for primary outcome measure)
To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00171977 on ClinicalTrials.gov Archive Site
  • To evaluate overall survival, relapse free [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as measured by the confirmation of tumor recurrence and survival for 3 years after surgery for their primary tumors.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastrointestinal Stromal Tumors
Drug: Imatinib Mesylate
Other Names:
  • Gleevec/Glivec
  • STI571
Experimental: Imatinib Mesylate
400 mg once per day
Intervention: Drug: Imatinib Mesylate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
Not Provided
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • underwent macroscopically curative resection;
  • immunohistochemically confirmed KIT (CD117)-positive tumors;
  • judged as being high-risk according to the criteria for risk classification

Exclusion Criteria:

  • synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years;
  • received therapy with Imatinib Mesylate prior to study entry;
  • cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria)

Other protocol-defined inclusion / exclusion criteria may apply.

Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00171977
CSTI571BJP07
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP