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Advanced Hepatocellular CarcinomaPhase 1/2NCT00731445

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

A Phase 1/2 study testing Z-208 in people with Advanced Hepatocellular Carcinoma, run by Zeria Pharmaceutical at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
Z-208
Type of treatment
Pill or oral medicine
How many people
43 participants
Where
1 siteJapan
Study dates
Jul 2008to Jun 2012
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • The University of Tokyo Hospital

    Tokyo

Other trials in Japan

About this study

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

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.

Being tested
Z-208
Keywords
Z-208

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Z-208Drug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 28 days

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

    Measured: 28 days for 6 courses

Secondary outcomes (4)

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

    Measured: 28 days for 6 courses

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

    Measured: 28 days for 6 courses

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

    Measured: 28 days for 6 courses

  4. Phase II: Determine the PFS

    Measured: 28 days for 6 courses

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJan 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00731445
Sponsor's protocol ID
07010101
Status last verified
Jun 2012
First submitted
8 Aug 2008
Last updated
3 Jul 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Z-208 in people with Advanced Hepatocellular Carcinoma, run by Zeria Pharmaceutical at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Determine the maximum tolerated dose (MTD) of Z-208 in patients with advanced hepatocellular carcinoma (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00731445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2012; AzTrials last refreshed its copy on 7 Nov 2026.

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