Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00441155 |
To provide study drug to patients that benefit from treatment judged by the investigator - to obtain additional long-term safety and efficacy data of this combination regimen in GIST
Condition | Intervention | Phase |
---|---|---|
Gastrointestinal Stromal Tumors |
Drug: Nilotinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Extension to a Phase I Multicenter, Dose Escalation Study of Nilotinib 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: | November 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Other protocol defined inclusion/exclusion criteria may apply.
Study ID Numbers: | CAMN107A2103E1 |
Study First Received: | February 26, 2007 |
Last Updated: | May 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00441155 |
Health Authority: | United States: Food and Drug Administration |
Oncology Cancer Imatinib-Resistant Gastrointestinal Stromal Tumors |
GIST Nilotinib Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST) |
Imatinib Digestive System Diseases Digestive System Neoplasms |
Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |