Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Novartis Pharmaceuticals |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00867113 |
This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The purpose of this trial is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST.
Condition | Intervention | Phase |
---|---|---|
Gastrointestinal Stromal Tumor (GIST) |
Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Non-Randomized, Open-Label Multicenter Study of 5 Year Adjuvant Imatinib Mesylate (Gleevec®) in Patients at Significant Risk for Recurrence Following Complete Resection of Primary Gastrointestinal Stromal Tumor (GIST) |
Estimated Enrollment: | 133 |
Study Start Date: | June 2009 |
Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Imatinib Mesylate: Experimental
Patients at Significant Risk for Recurrence Following Complete Resection of Primary Gastrointestinal Stromal Tumor (GIST)
|
Drug: imatinib mesylate
imatinib mesylate 400 mg once per day by mouth for 5 years.
|
This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The primary endpoint is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST. A total of 133 adult patients, 18 years of age and older will be enrolled.Participants will take 400 mg of imatinib mesylate daily by mouth for a total of 5 years. At the conclusion of the treatment period, patients will be followed for 5 years for survival, status of response, antineoplastic treatments and quality of life.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient must be at significant risk of tumor recurrence as defined by either:
Patient must have the following post-operative laboratory values confirmed within 14 days prior to first dose of imatinib study drug:
If patient is a cancer survivor, ALL of the following criteria apply:
Exclusion Criteria:
Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
-
Contact: Novartis Pharmaceuticals | +1-800-340-6843 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CSTI571BUS282 |
Study First Received: | March 20, 2009 |
Last Updated: | August 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00867113 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Imatinib Protein Kinase Inhibitors Gastrointestinal Stromal Tumors Digestive System Diseases Digestive System Neoplasms |
Gastrointestinal Diseases Gastrointestinal Neoplasms Adjuvant PERSIST PERSIS-5 |
Imatinib Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Adjuvants, Immunologic |
Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Protein Kinase Inhibitors Recurrence |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Imatinib Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |