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Hepatocellular CarcinomaPhase 2NCT00423306

A Phase-II Trial of ZIO 101 in Advanced Hepatocellular Carcinoma

A Phase 2 study testing Darinaparsin in people with Hepatocellular Carcinoma, run by Alaunos Therapeutics at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study of safety of a new organic arsenic compound in the treatment of advanced hepatocellular carcinoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Darinaparsin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
6 sitesUnited States
Study dates
1 May 2007to 9 Aug 2008
Phase
Phase 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HCC diagnosed by histology or clinical evidence supported by liver mass(es) at least 2cm in the longest diameter and AFP equal to or more than 500 ng/mL in cirrhosis or chronic HBV or HCV infection27.
  • Male or female patients ≥ 18 years of age
  • Patients who have a life expectancy of at least 12 weeks
  • Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST).
  • Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 - 2 (see Appendix 4).
  • Patients who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemo-embolization, radio-frequency ablation or cryo-ablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of ≥ 25% in the size. Furthermore, the local therapy applied to target or non-target lesions needs to have been completed at least 8 weeks prior to study inclusion. Lesions treated with external beam radiation therapy are not acceptable as target lesions, unless they fulfil the conditions described above.
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  • No more than one prior chemotherapy based regimen is allowed. Patients can receive up to two regimes where target therapies have been used (washout)
  • Cirrhotic status of Child-Pugh Class A or B only (Appendix 5).
  • Adequate hepatic function at screening as assessed by the following:
  • Platelet count ≥ 60 x 109/L
  • Hemoglobin ≥ 8.5 g/dl
  • Total bilirubin ≤ 3 mg/dl
  • ALT and AST ≤ 5 x upper limit of normal
  • Serum creatinine ≤ 2.0 x the upper limit of normal
  • PT-INR ≤ 2.3 or PT ≤ 6 seconds above control
  • Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Who cannot join

  • Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis and T1] or other malignancies curatively treated > 2 years prior to entry)
  • Congestive heart failure > NYHA Class II
  • Cardiac arrhythmias requiring anti-arrythmics (excluding beta blockers or digoxin for chronic stable atrial fibrillation) or QTc greater than 450 msec.
  • Active coronary artery disease or cardiac ischemia
  • Active clinically serious bacterial, viral or fungal infections (> grade 2 NCI-CTCAE, Version 3)
  • Known history of human immunodeficiency virus (HIV) infection for less than 2 years or uncontrolled disease on antiretroviral medication
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  • Metastatic brain or meningeal tumors
  • Patients with seizure disorder requiring medication (such as anti-epileptics)
  • History of confusion or dementia or neurological condition that could mask a potential adverse response to the study drug (or something along these lines)
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 14 days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Boston, Massachusetts

  • Study site

    Kansas City, Missouri

  • Study site

    Miami, Florida

  • Study site

    New York, New York

  • Study site

    Seattle, Washington

Other trials in United States

About this study

The study of safety of a new organic arsenic compound in the treatment of advanced hepatocellular carcinoma

Being tested
Darinaparsin
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • DarinaparsinDrug

    Also called ZIO-101

    420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest, for up to 6 months

Study groups in NCT00423306
Study groupRoleWhat they receive
Single ArmExperimentalNot described
Receives: Drug: Darinaparsin

What is being measured

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

  1. Response Rate

    Measured: 6 months

Secondary outcomes (2)

  1. Survival (overall and progression free)

    Measured: 6 months

  2. toxicities

    Measured: 6 months

Timeline

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

  1. First posted18 Jan 2007 (estimated)
  2. Study start1 May 2007
  3. Primary completion9 Aug 2008
  4. Study completion9 Aug 2008

Why it stopped: Study closed after Stage 1 (15 of 40 planned patients treated) due to lack of treatment response; criteria to proceed to Stage 2 were not met.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00423306
Sponsor's protocol ID
SGL2005
Status last verified
Sep 2026
First submitted
16 Jan 2007
Last updated
1 Oct 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Darinaparsin in people with Hepatocellular Carcinoma, run by Alaunos Therapeutics at 6 sites in United States.

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 16 inclusion and 14 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: stopped early, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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 phase mean?

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 was stopped early (reason given: Study closed after Stage 1 (15 of 40 planned patients treated) due to lack of treatment response; criteria to proceed to Stage 2 were not met.). Results are not available in the source record.

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?

Response Rate (time frame: 6 months). 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 NCT00423306.

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 1 Oct 2026.

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