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:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT00095992
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed hepatocellular carcinoma
* Locally advanced, recurrent, or metastatic disease
* Histologically confirmed disease must have archival paraffin-fixed tumor specimen available
* Measurable disease
* At least 1 unidimensionally measurable site of disease ≥ 20 mm by x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm by spiral CT scan
* Outside of previously irradiated area
* Patients whose sole site of disease is in a previously irradiated field are eligible provided there is evidence of disease progression OR new lesions documented in the irradiated field
* Bone metastases are not considered measurable disease
* Not curable by standard therapies
* No cholangiocarcinoma
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 80,000/mm\^3
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST ≤ 5 times ULN
* Must have hepatic reserve of Child-Turcotte-Pugh class A or better
Renal
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No myocardial infarction within the past 6 months
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No active cardiomyopathy
* No uncontrolled hypertension
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No clinical evidence of encephalopathy
* No ongoing or active infection
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to SB-715992
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 4 weeks since prior intra-hepatic chemotherapy as a component of trans-arterial chemoembolization and recovered
* Documented disease progression
* No prior systemic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy
Surgery
* At least 4 weeks since prior major surgery
* Prior liver transplantation allowed
Other
* No other prior systemic therapy
* At least 4 weeks since prior local ablative therapy (e.g., radiofrequency ablation or ethanol injection) and recovered
* Documented disease progression
* More than 28 days since prior investigational agents
* More than 14 days since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:
* Clarithromycin
* Erythromycin
* Troleandomycin
* Itraconazole
* Ketoconazole
* Fluconazole (dose \> 200 mg/day)
* Voriconazole
* Nefazodone
* Fluvoxamine
* Verapamil
* Diltiazem
* Grapefruit juice
* Bitter orange
* Phenytoin
* Carbamazepine
* Phenobarbital
* Oxcarbazepine
* Rifampin
* Rifabutin
* Rifapentine
* Hypericum perforatum (St. John's wort)
* Modafinil
* At least 6 months since prior and no concurrent amiodarone
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent anticancer therapy
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00095992
Study Brief:
Protocol Section:
NCT00095992