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Brief Title: Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)
Official Title: A Phase I Multicenter, Dose Escalation Study of AMN107 in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant Gastrointestinal Stromal Tumors (GIST)
Study ID: NCT00135005
Brief Summary: This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Novartis Investigative Site, Boston, Massachusetts, United States
Novartis Investigative Site, Philadelphia, Pennsylvania, United States
Novartis Investigative Site, Lyon Cedex, , France
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Milano, MI, Italy
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR