A Phase-II Trial of ZIO 101 in Advanced Hepatocellular Carcinoma
1 other identifier
interventional
15
1 country
6
Brief Summary
The study of safety of a new organic arsenic compound in the treatment of advanced hepatocellular carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hepatocellular-carcinoma
Started Jan 2007
Longer than P75 for phase_2 hepatocellular-carcinoma
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 16, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedNovember 14, 2013
November 1, 2013
6.9 years
January 16, 2007
November 13, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Response Rate
6 months
Secondary Outcomes (2)
Survival (overall and progression free)
6 months
toxicities
6 months
Study Arms (1)
Single Arm
EXPERIMENTALInterventions
420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest, for up to 6 months
Eligibility Criteria
You may qualify if:
- 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).
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Miami, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2007
First Posted
January 18, 2007
Study Start
January 1, 2007
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
November 14, 2013
Record last verified: 2013-11