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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MB07133 Dose Level 1 | Experimental | 7-day continuous infusion in 28-day cycles |
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| MB07133 Dose Level 2 | Experimental | 7-day continuous infusion in 28-day cycles |
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| MB07133 Dose Level 3 | Experimental | 7-day continuous infusion in 28-day cycles |
|
| MB07133 Dose Level 4 | Experimental | 7-day continuous infusion in 28-day cycles |
|
| MB07133 Dose Level 5 | Experimental | 7-day continuous infusion in 28-day cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MB07133 300mg/m2/day | Drug | 7-day continuous infusion in 28-day cycles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | To determine the dose-limiting toxicities (DLT) of MB07133; To determine the maximum-tolerated continuous infusion dose (MTD) of MB07133 | 7-day continuous infusion every 28-days as tolerated |
| Measure | Description | Time Frame |
|---|---|---|
| Determine effect of MB07133 on tumor size | To determine the effect on HCC tumor size by using CT scanning, alpha-fetoprotein (AFP) concentration, and performance status. | 28 day cycles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabela Niculae, MPH | Metabasis Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Irvine | Orange | California | 92868 | United States | ||
| Prince of Wales Hospital - Comprehensive Cancer Trial Unit |
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| MB07133 600 mg/m2/day |
| Drug |
7-day continuous infusion in 28-day cycles |
|
| MB07133 1200 mg/m2/day | Drug | 7-day continuous infusion in 28-day cycles |
|
| MB07133 1800 mg/m2/day | Drug | 7-day continuous infusion in 28-day cycles |
|
| MB07133 2400 mg/m2/day | Drug | 7-day continuous infusion in 28-day cycles |
|
| Shatin, New Territories |
| Hong Kong |
| Tri-Services General Hospital | Taipei | Nei Hu District | 114 | Taiwan |
| Chang-Gung Memorial Hospital | Taipei | Taoyuan County | 333 | Taiwan |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D002277 | Carcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C497722 | 4-amino-1-(5-O-(2-oxo-4-(4-pyridyl)-1,3,2-dioxaphosphorinan-2-yl)arabinofuranosyl)-2(1H)-pyrimidinone |
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