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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborators: |
Novartis Bayer |
| Information provided by (Responsible Party): | Jennifer Chan, MD, MPH, 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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | August 2012 (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| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Jennifer Chan, MD, MPH | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Jennifer Chan, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00942682 History of Changes |
| Other Study ID Numbers: | 09-094 |
| Study First Received: | July 17, 2009 |
| Last Updated: | February 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
sorafenib RAD001 |
|
Carcinoid Tumor Neuroendocrine Tumors Adenoma, Islet Cell Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Adenoma Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Sirolimus Everolimus Sorafenib Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors |