Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT00321594
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed hepatocellular carcinoma that is not amenable to curative resection
* Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with MRI or spiral CT scan
* No known brain metastases
* No clinical ascites or encephalopathy
* Life expectancy \> 12 weeks
* ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
* WBC ≥ 3,000/mm³
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.7 mg/dL
* Albumin ≥ 2.8 mg/dL
* ALT ≤ 5.0 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 6 times ULN
* Prothrombin time ≤ 4 sec above ULN
* Creatinine ≤ 1.6 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients use effective contraception
* No Child's-Pugh's grading Class C hepatic impairment
* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to PXD101
* No marked baseline prolongation of QT/QTc interval, including the following:
* Repeated demonstration of a QTc interval \> 500 msec
* Long QT Syndrome
* No ongoing or active infection
* No significant cardiovascular disease, including any of the following:
* Unstable angina pectoris
* Uncontrolled hypertension
* Congestive heart failure related to primary cardiac disease
* Condition requiring anti-arrhythmic therapy
* Ischemic or severe valvular heart disease
* Myocardial infarction within the past 6 months
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
* More than 4 weeks since prior radiotherapy and recovered
* At least 2 weeks since prior valproic acid
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent participation in another investigational study
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* No concurrent use of any of the following:
* Disopyramide
* Dofetilide
* Ibutilide
* Procainamide
* Quinidine
* Sotalol
* Bepridil
* Amiodarone
* Arsenic trioxide
* Cisapride
* Calcium channel blockers (e.g., lidoflazine)
* Clarithromycin
* Erythromycin
* Halofantrine
* Pentamidine
* Sparfloxacin
* Domperidone
* Droperidol
* Chlorpromazine
* Haloperidol
* Mesoridazine
* Thioridazine
* Pimozide
* Methadone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00321594
Study Brief:
Protocol Section:
NCT00321594