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Sponsors and Collaborators: |
Massachusetts General Hospital Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Novartis |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00516165 |
Laboratory studies have shown that RAD001 can prevent cells from multiplying. Consequently, the study drug is being tested in medical conditions in which excessive cell multiplication (as in cancer) needs to be stopped. The main purpose of this research study is to find the highest dose of RAD001 that can be given safely (without causing severe side effects) and to learn the effects (good or bad) RAD001 has on participants with liver cancer.
Condition | Intervention | Phase |
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Hepatocellular Carcinoma |
Drug: RAD001 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of RAD001 in Advanced Hepatocellular Carcinoma |
Estimated Enrollment: | 40 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | August 2009 (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: Andrew X Zhu, MD, PhD | 617-724-0786 | azhu@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: Andrew X. Zhu, MD, PhD | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Charles Fuchs, MD | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Principal Investigator: Sanjay Jain, MD, PhD |
Principal Investigator: | Andrew X. Zhu, MD, PhD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Andrew Zhu, MD ) |
Study ID Numbers: | 06-352 |
Study First Received: | August 13, 2007 |
Last Updated: | December 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00516165 History of Changes |
Health Authority: | United States: Food and Drug Administration |
liver cancer RAD001 |
Everolimus Liver Diseases Digestive System Neoplasms Immunologic Factors Carcinoma, Hepatocellular Immunosuppressive Agents Carcinoma |
Liver Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular Carcinoma Neoplasms, Glandular and Epithelial |
Everolimus Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Immunologic Factors Carcinoma, Hepatocellular Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Carcinoma Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |