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Complete title: POLARIS2009-001: A Randomized, Double-Blind, Multi-Center Phase 3 Study of ADI PEG 20 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed Prior Systemic Therapy
|Research Study Number||20120106|
|Principal Investigator||William Harris|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Prior diagnosis of HCC confirmed histologically.
- Prior treatment with at least 1 systemic agent, with documented progressive disease after systemic agent(s), or adverse event(s)associated with prior systemic agent(s) that resulted in discontinuance of that agent(s).
- Cirrhotic status of Child-Pugh grade B7.
- Expected survival of at least 3 months.
- Adequate hematologic, hepatic, and renal function.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Significant cardiac disease.
- Serious infection requiring treatment with systemically administered antibiotics.
- Pregnancy or lactation.
- Expected non-compliance.
- Uncontrolled intercurrent illness, or psychiatric illness or social situations that would limit compliance with study requirements.
- Subjects who have had any anticancer treatment within 2 weeks prior to entering the study.
- Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies.
- Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis.
- Allergy to pegylated products.
- Bleeding esophageal or gastric varices within the prior three months, except if banded or treated.
- Subjects known to be HIV positive.
- Uncontrolled ascites (defined as not easily controlled with diuretic treatment).
- Having received any blood transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony stimulating factors (G-CSF) within 7 days prior to screening laboratories or after screening laboratories have been obtained until first dose of study drug or placebo.
- Use of traditional medicines approved by local authorities, including but not limited to Chinese herbs within 14 days of first dose of study drug or placebo.
- ECOG performance status > 2.
- Prior allograft,including liver transplant.
Other exclusion criteria may apply.
Liver Cancer; Solid Tumors
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