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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00050349 |
Purpose
This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause metastatic carcinoid and other neuroendocrine tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoid Neuroendocrine Tumors |
Drug: EPO906 epothilone B |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | EPO906 Therapy in Patients With Metastatic Carcinoid Tumors and Other Neuroendocrine Tumors |
| Enrollment: | 32 |
| Study Start Date: | July 2002 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: EPO906 | Drug: EPO906 epothilone B |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Illinois | |
| Northwestern/Hematology Oncology Clinic | |
| Chicago, Illinois, United States, 60611 | |
| United States, Iowa | |
| University of Iowa Holden Cancer Center | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Louisiana | |
| Louisiana State University Medical Center | |
| New Orleans, Louisiana, United States, 70112-1393 | |
| United States, New York | |
| Weill Medical College at Cornell University, Dept. Hem/Onc | |
| New York, New York, United States, 10065 | |
| United States, Oregon | |
| Oregon Health and Sciences University | |
| Portland, Oregon, United States, 97239-3098 | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00050349 History of Changes |
| Other Study ID Numbers: | CEPO906A2212 |
| Study First Received: | December 4, 2002 |
| Last Updated: | August 26, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
cancer tumor tumour neoplasm carcinoma carcinoid neuroendocrine |
Islet cell Gastrinoma VIPoma metastatic intravenous epothilone |
|
Carcinoid Tumor Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Epothilone B Epothilones Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |