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Novartis Clinical
Trials provides information about research studies recruiting
within the U.S. Visit ClinicalTrials.gov, a registry of federally and privately supported clinical trial for more information regarding clinical trials outside of the U.S. |
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Gastrointestinal Stromal Tumor (GIST)
These quite rare tumors represent about 20% of the benign and malignant tumors of the small bowel. It's sometimes difficult to distinguish between benign connective tissue tumors and low-grade cancers of the muscle wall of the small gut. Malignant tumors of this type can produce intestinal obstruction or perforation, and spread within the abdominal cavity is common.
Novartis is seeking people to participate in a clinical trial(s) testing the safety and effectiveness of Novartis products. Novartis recommends that you consult your doctor before participating in a clinical trial. For more information about clinical trial participation, click here. Also, for additional information about how Novartis helps to protect the privacy of the personal information that you provide to us, please see the Novartis Privacy Policy. Please review the details of the clinical trial(s) listed below and click on the one that you feel best suits your (or the participant's) condition.
Metastatic Unresectable Gastrointestinal Stromal Tumors (GIST) Study CAMN107G2301
The purpose of this clinical trial is to compare the safety and effectiveness of a Novartis investigational drug to imatinib (Gleevec®) in patients with inoperable and/or metastatic Gastrointestinal Stromal Tumors (GIST) who are either newly diagnosed or have experienced recurrences of the disease after stopping treatment with imatinib (Gleevec®). An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
Trial phase: Phase 3 Participation Duration: Participants enrolling in this study will be required to visit the study center 4 times within the first month. Follow up visits will be required every 3 months until the trial is complete (up to 10 years). Protocol Number: CAMN107G2301 Gastrointestinal Stromal Tumor (GIST) Study CSTI571BUS282
This study is being done to find out if taking the drug Gleevec® for five years will stop or delay tumor recurrence in patients who have had an operation to remove their gasterointestinal stromal tumor. In December of 2008, Gleevec® become the first FDA approved treatment option available to patients to prevent gasterointestinal stromal tumors from coming back after they are removed with surgery. Although Gleevec® was approved, the optimal length of treatment has not been established and for now it is recommended for at least one year.
Trial phase: Phase 2 Participation Duration: Participants will be required to visit the study center 3 times within the first month, and then once every 4 months until the study is completed. At the conclusion of your treatment with Gleevec®, your doctor’s office will contact you twice a year for five years. Protocol Number: CSTI571BUS282 |