Know Cancer

forgot password

Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral Z-208 in Patients With Advanced Hepatocellular Carcinoma

Phase 1/Phase 2
20 Years
79 Years
Not Enrolling
Advanced Hepatocellular Carcinoma

Thank you

Trial Information

Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral Z-208 in Patients With Advanced Hepatocellular Carcinoma

This is an open-label, dose-escalation study PhaseI Treatments repeats for 28 days for 1
course in the unacceptable toxicity

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.

Inclusion Criteria

Inclusion criteria:

- Histologically or cytologically confirmed hepatocellular carcinoma

- 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

- Patients received treatment with any of the following within the specified
timeframe;Any surgical procedure, radiofrequency ablation, intraarterial chemotherapy
within 30 days prior to signing the ICF, any treatment with transfusion, albumin
preparation, G-CSF within 15 days prior to signing the ICF

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Determine the maximum tolerated dose (MTD) of Z-208 in patients with advanced hepatocellular carcinoma

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Masao Omata, PhD, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The University of Tokyo


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

July 2008

Completion Date:

June 2012

Related Keywords:

  • Advanced Hepatocellular Carcinoma
  • Z-208
  • Carcinoma
  • Carcinoma, Hepatocellular