Trial record 91 of 350 for: Gastrointestinal Stromal Tumors

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

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ClinicalTrials.gov Identifier: NCT00171977

Recruitment Status : Completed

First Posted : September 15, 2005

Last Update Posted : August 7, 2012

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Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Gastrointestinal Stromal Tumors	Drug: Imatinib Mesylate	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	64 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
Study Start Date :	July 2004
Actual Primary Completion Date :	April 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gastrointestinal stromal tumor

Drug Information available for: Imatinib Imatinib mesylate

Genetic and Rare Diseases Information Center resources: Gastrointestinal Stromal Tumors

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Imatinib Mesylate 400 mg once per day	Drug: Imatinib Mesylate Other Names: Gleevec/Glivec STI571

Outcome Measures

Primary Outcome Measures :

To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy [ Time Frame: 3 years ]

Secondary Outcome Measures :

To evaluate overall survival, relapse free [ Time Frame: 3 years ]
Safety [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 74 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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): NCT00171977

Locations

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Japan
Novartis Investigative Site
Tokyo, Japan

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

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Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kanda T, Nishida T, Wada N, Kobayashi O, Yamamoto M, Sawaki A, Boku N, Koseki M, Doi T, Toh Y, Kakeji Y, Sugiyama T, Komatsu Y, Kikuchi S, Ogoshi K, Katai H, Miyachi K, Hirota S, Ohtsu A. Adjuvant therapy with imatinib mesylate after resection of primary high-risk gastrointestinal stromal tumors in Japanese patients. Int J Clin Oncol. 2013 Feb;18(1):38-45. doi: 10.1007/s10147-011-0339-7. Epub 2011 Nov 23.

Essat M, Cooper K. Imatinib as adjuvant therapy for gastrointestinal stromal tumors: a systematic review. Int J Cancer. 2011 May 1;128(9):2202-14. doi: 10.1002/ijc.25827.

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Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00171977
Other Study ID Numbers:	CSTI571BJP07
First Posted:	September 15, 2005 Key Record Dates
Last Update Posted:	August 7, 2012
Last Verified:	August 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


GIST Imatinib Postoperative Adjuvant

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 Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

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