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CompletedNCT00731445Updated Jul 3, 2012

Phase I/II Study of Z-208 in Advanced Hepatocellular Carcinoma (HCC)

A Phase 1/2 interventional study of Z-208 in Advanced Hepatocellular Carcinoma, sponsored by Zeria Pharmaceutical. Completed at 1 site in Japan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2012-07-03.

Sponsored by Zeria Pharmaceutical · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
20 Years to 79 Years
Sex
All
01

Study summary

This phase I/II is studying the side effect and best dose of Z-208 for patients with advanced hepatocellular carcinoma

Read the detailed description

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.

02

Conditions studied

  • Advanced Hepatocellular Carcinoma

Keywords

  • Z-208
03

In context

Lead sponsor

Zeria Pharmaceutical is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (estimated)

Interventions

  • DrugZ-208

    Oral pills taken daily; 8mg, 12mg, 16mg, 4mg

06

What researchers measure

Primary outcomes

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

    Time frame: 28 days

  2. Phase II : Assess the objective tumor response rate in patients according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria

    Time frame: 28 days for 6 courses

Secondary outcomes

  1. Phase I : Assess the objective tumor response rate in patients according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria

    Time frame: 28 days for 6 courses

  2. Phase I : Determine the pharmacokinetics of this drug in these patients

    Time frame: 28 days for 6 courses

  3. Phase I : Determine the adverse effects profile of this drug in these patients

    Time frame: 28 days for 6 courses

  4. Phase II: Determine the PFS

    Time frame: 28 days for 6 courses

07

Study locations

1 site
  • The University of Tokyo Hospital
    Tokyo, Japan
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2008, a primary completion of Jan 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2008
First posted
Aug 11, 2008
Start
Jul 2008
Primary completionActual
Jan 2012
CompletionActual
Jun 2012
Last update
Jul 3, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00731445
First posted
Aug 11, 2008
Start date
Jul 2008
Primary completion
Jan 2012
Completion
Jun 2012
Last update
Jul 3, 2012

Study contacts

Masao Omata, PhD, MD
study chair · Tokyo University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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