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Sponsors and Collaborators: |
National Health Research Institutes, Taiwan Novartis |
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Information provided by: | National Health Research Institutes, Taiwan |
ClinicalTrials.gov Identifier: | NCT00390195 |
The mTOR has been examined in hepatocellular carcinomas as well. This pathway is up-regulated in a proportion of hepatocellular carcinoma (HCC) and that rapamycin inhibits cell proliferation and blocks S6K phosphorylation. Inhibition of mTOR had been shown to suppress substantially the liver tumor growth.
Nevertheless, inhibition of mTOR was demonstrated to have a clinical response in some cancer types. These reports imply that inhibition of mTOR could be a promising therapeutic strategy in the treatment of HCC. Therefore, we hypothesize that RAD001, a rapamycin analog, can inhibit the mTOR, and subsequently suppress the liver tumor in the treatment of HCC patients.
This study is aimed to investigate the safety, efficacy, pharmacokinetics, pharmacogenetics and feasibility of RAD001 in advanced HCC patients. This study will be a randomized phase I study with dose escalation and subsequently a phase II study of intent to treat, as well as pharmacokinetic, pharmacogenetic and surrogate marker study of RAD001.
Condition | Intervention | Phase |
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Hepatocellular Carcinoma |
Drug: RAD001 (everolimus) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase I/II of Rapamycin Analog, RAD001, in Advanced Hepatocellular Carcinoma - With a Pharmacokinetic Study of RAD001 |
Estimated Enrollment: | 134 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1. Daily: Experimental
Taking orally the investigational drug daily
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Drug: RAD001 (everolimus)
Arm 1: 2.5, 5, 7.5 or 10 mg of RAD001 daily
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2. Weekly: Experimental
Taking orally the investigational drug weekly
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Drug: RAD001 (everolimus)
Arm 2: 20, 30, 50 or 70 mg of RAD001 daily
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Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Her-Shyong Shiah, M.D. | 886-2-8792-3311 ext 17624 | hsshiah@nhri.org.tw |
Taiwan | |
Tri-Service General Hospital | Active, not recruiting |
Taipei, Taiwan, 11490 | |
National Cheng Kung University Hospital | Recruiting |
Tainan, Taiwan, 704 | |
Contact: Her-Shyong Shiah, M.D. +886-6-208-3422 ext 65113 hsshiah@nhri.org.tw | |
Principal Investigator: Li-Tzong Chen, M.D., Ph.D. | |
Sub-Investigator: Jang-Yang Chang, M.D. | |
Sub-Investigator: Wu-Chou Su, M.D. | |
Sub-Investigator: Her-Shyong Shiah, M.D. |
Principal Investigator: | Li-Tzong Chen, M.D., Ph.D. | National Institute of Cancer Research, National Health Research Institutes, Taiwan |
Responsible Party: | Deputy Director ( National Institute of Cancer Research, National Health Research Instiutes ) |
Study ID Numbers: | CRAD001C2453 |
Study First Received: | October 17, 2006 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00390195 History of Changes |
Health Authority: | Taiwan: Department of Health |
Hepatocellular carcinoma RAD001 Rapamycin Randomize |
Phase I Phase II Pharmacokinetics |
Sirolimus 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 |