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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborators: |
Novartis Bayer |
| Information provided by: | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00942682 |
Purpose
The purpose of this research study is to find out more about the combination of RAD001 and sorafenib such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating neuroendocrine tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroendocrine Tumor Carcinoid Tumor Pancreatic Neuroendocrine Tumor |
Drug: Sorafenib Drug: RAD001 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
| Official Title: | Phase I Study of Sorafenib in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors |
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jennifer Chan, MD, MPH | jennifer_chan@dfci.harvard.edu |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Jennifer Chan, MD, MPH | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Dana-Farber Cancer Institute ( Jennifer Chan, MD, MPH ) |
| Study ID Numbers: | 09-094 |
| Study First Received: | July 17, 2009 |
| Last Updated: | July 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00942682 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
sorafenib RAD001 |
|
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Neoplasms, Nerve Tissue Physiological Effects of Drugs Protein Kinase Inhibitors Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Endocrine Gland Neoplasms Everolimus Neoplasms by Histologic Type Digestive System Neoplasms Endocrine System Diseases |
Enzyme Inhibitors Adenoma, Islet Cell Immunosuppressive Agents Pharmacologic Actions Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Digestive System Diseases Pancreatic Diseases Carcinoid Tumor Adenocarcinoma Adenoma Sorafenib Neoplasms, Glandular and Epithelial |