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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00135005 |
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.
Condition | Intervention | Phase |
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Gastrointestinal Stromal Tumors |
Drug: AMN107, STI571 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 60 |
Study Start Date: | August 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
NOTE: Additional inclusion and/ or exclusion criteria may apply.
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 |
Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Study ID Numbers: | CAMN107A2103 |
Study First Received: | August 23, 2005 |
Last Updated: | December 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00135005 |
Health Authority: | United States: Food and Drug Administration |
GIST AMN107 Gastrointestinal Stromal Tumors |
Imatinib Digestive System Diseases Digestive System Neoplasms |
Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |
Neoplasms Neoplasms by Site |