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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00756509 |
The purpose of this multicenter, single-arm, exact binomial single-stage, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors
Condition | Intervention | Phase |
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Gastrointestinal Stromal Tumors |
Drug: Nilotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Multi-Center, Single-Arm Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line Treatment |
Estimated Enrollment: | 40 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Nilotinib
800 mg/d orally
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have the following laboratory values (≥ LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication.):
Patients must have normal organ, electrolyte, and marrow function as defined below:
Exclusion Criteria:
Impaired cardiac function at including any one of the following:
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CAMN107DDE06, EUDRACT- Nr. 2008-000358-11 |
Study First Received: | September 19, 2008 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00756509 History of Changes |
Health Authority: | United States: Institutional Review Board; Germany: Federal Institute for Drugs and Medical Devices |
unresectable or metastatic GIST 1st. line treatment |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |