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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Brigham and Women's Hospital Massachusetts General Hospital Faulkner Hospital Novartis |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00804336 |
The purpose of this research study is to determine the safety of the combination of SOM230 and RAD001, as well as determine the highest dose of this combination that can be given to people safely. SOM230 is an investigational drug that is similar to Sandostatin LAR. Sandostatin is an approved drug for the use of treating symptoms of neuroendocrine tumors. SOM230 has shown to be effective in patients who have become resistant to Sandostatin and may also stop cancer cells from growing. RAD001 is an investigational drug that also may stop cancer cells from growing.
Condition | Intervention | Phase |
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Neuroendocrine Tumor Carcinoid Tumor Pancreatic Neuroendocrine Tumor |
Drug: SOM230 Drug: RAD001 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | Phase I Study of Pasireotide (SOM230) in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors |
Estimated Enrollment: | 32 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Chan, MD, MPH | 617-632-5960 | |
Contact: Michele Vincitore | 617-632-5960 |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Jennifer Ang Chan, MD, MPH | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02214 | |
Principal Investigator: David Ryan, MD | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Sanjay Jain, MD, PhD |
Principal Investigator: | Jennifer Ang Chan, MD, MPH | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Jennifer Ang Chan, MD, MPH ) |
Study ID Numbers: | 08-087 |
Study First Received: | December 5, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00804336 |
Health Authority: | United States: Food and Drug Administration |
pasireotide SOM230 RAD001 |
Everolimus Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Adenoma, Islet Cell Neuroendocrine Tumors Carcinoma Carcinoid tumor Neuroectodermal Tumors Digestive System Diseases |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Pancreatic Diseases Gastrointestinal Neoplasms Carcinoid Tumor Endocrinopathy Adenocarcinoma Adenoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors |
Physiological Effects of Drugs Neoplasms, Nerve Tissue Immunosuppressive Agents Pharmacologic Actions |