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| Sponsor: | Metabasis Therapeutics, Inc. |
|---|---|
| Information provided by: | Metabasis Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00073736 |
Purpose
Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver. MB07133 is being developed for the treatment of inoperable HCC, using a platform technology known as HepDirectTM, which enables drugs to be targeted specifically to the liver. The objective for this study is to determine the safety and tolerability of MB07133.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Drug: MB07133 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
| Official Title: | A Phase 1/2 Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous Infusion of MB07133 in Subjects With Unresectable Hepatocellular Carcinoma and Child-Pugh Class A Liver Function |
| Estimated Enrollment: | 36 |
| Study Start Date: | September 2003 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
To determine the maximum tolerated dose of MB07133 when administered as a 7-day continuous i.v. To characterize the safety profile and the pharmacokinetics of MB07133 and metabolites during and after continuous infusion. To determine the effect of MB07133 on hepatocellular carcinoma (HCC) tumor size.
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, California | |
| University of California at Irvine | |
| Orange, California, United States, 92868 | |
| Hong Kong | |
| Prince of Wales Hospital - Comprehensive Cancer Trial Unit | |
| Shatin, New Territories, Hong Kong | |
| Taiwan, Nei Hu District | |
| Tri-Services General Hospital | |
| Taipei, Nei Hu District, Taiwan, 114 | |
| Taiwan, Taoyuan County | |
| Chang-Gung Memorial Hospital | |
| Taipei, Taoyuan County, Taiwan, 333 | |
| Study Director: | Isabela Niculae, MPH | Metabasis Therapeutics, Inc. |
More Information
| Responsible Party: | Metabasis Therapeutics, Inc. ( Howard Foyt, MD/VP, Clinical Development ) |
| Study ID Numbers: | HCC-101 |
| Study First Received: | December 3, 2003 |
| Last Updated: | February 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00073736 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hepatocellular Carcinoma Liver Cancer |
|
Liver Neoplasms Liver Diseases Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Neoplasms by Histologic Type Carcinoma, Hepatocellular Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |