Phase I/II Study of Z-208 in Advanced Hepatocellular Carcinoma (HCC)
NCT ID: NCT00731445
Last Updated: 2012-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
43 participants
INTERVENTIONAL
2008-07-31
2012-06-30
Brief Summary
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Detailed Description
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Cohort of 3 patients receive escalating doses of Z-208 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 patients experience dose-limiting toxicity.
PhaseII Treatments repeats for 28 days for 6 courses until absence of disease progression or unacceptable toxicity.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Z-208
Oral pills taken daily; 8mg, 12mg, 16mg, 4mg
Eligibility Criteria
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Inclusion Criteria
* At least one measurable site of disease according to RECIST criteria that has not been irradiated.
* Child-Pugh classification A \& B
* ECOG performance status of 0-1
* Life expectancy is more than 90 days
* Adequate organ function as defined by the following criteria, Hemoglobin ≥ 8.0 g/dL WBC ≥ 3,000/mm\^3 \<12,000/mm\^3 Absolute neutrophil count ≥ 1,500/mm\^3 Platelet count ≥ 50,000/mm\^3 AST and ALT ≤ 5 times upper limit of normal (ULN) Albumin ≥ 2.8 g/dL Bilirubin ≤ 2.0 mg/dL Creatinine ≤ 1.5 times ULN
* Must provide written informed consent prior to the implementation of any study assessment or procedures
Exclusion Criteria
* CNS involvement must have completed appropriate treatment
* Prior deep vein thrombosis
* Has ascites, pleural effusions or pericardial fluid refractory
* Active clinically serious infection excluding chronic hepatitis
* Any history of deep vein thrombosis, pulmonary embolism, myocardial infraction, cerebrovascular accident
* Allergy or hypersensitivity to Vitamin A
* Women who are pregnant or breast feeding
20 Years
79 Years
ALL
No
Sponsors
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Zeria Pharmaceutical
INDUSTRY
Responsible Party
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Zeria Pharmaceutical Co., Ltd
Principal Investigators
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Masao Omata, PhD, MD
Role: STUDY_CHAIR
Tokyo University
Locations
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The University of Tokyo Hospital
Tokyo, , Japan
Countries
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Other Identifiers
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07010101
Identifier Type: -
Identifier Source: org_study_id