Status:
COMPLETED
Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Intravenous TKM-080301 in Subjects With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Arbutus Biopharma Corporation
Conditions:
Hepatocellular Carcinoma
Hepatoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is an open-label, multi-center, phase 1, dose escalation study with a phase 2 expansion cohort to determine the safety, pharmacokinetics and preliminary anti-tumor activity of intravenous T...
Detailed Description
Study design: Open label, multi-center, 3 + 3 dose-escalation study with an expansion cohort at the maximum tolerated dose (MTD) to investigate safety, tolerability, PK, and preliminary anti-tumor act...
Eligibility Criteria
Inclusion
- Key
- Child-Pugh class of A
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5.0 × ULN
- Total bilirubin ≤3.0 mg/dL
- Platelets ≥75,000 /mL
- International Normalized Ratio (INR) ≤1.7
- Subjects must meet the protocol-defined criteria for both hepatitis B virus (HBV) and hepatitis C virus (HCV) status
- Key
Exclusion
- History of significant cardiovascular disease will be excluded
- History of liver transplant.
- Diagnosis of fibrolamellar HCC or tumors of mixed histology.
- Subjects known to be positive for Human immunodeficiency virus (HIV) infection.
- Known central nervous system (CNS) or brain metastases.
- Poorly controlled ascites and/or requirement for therapeutic paracentesis more frequently than once every 3 months.
- Symptomatic encephalopathy within 3 months prior to the first dose of TKM-080301 and/or requirement for medication for encephalopathy.
- Esophageal variceal bleeding within 2 weeks prior to the first dose of TKM-080301.
- Asthma or chronic obstructive pulmonary disease (COPD) requiring daily medication.
- Prior therapy with nitrosoureas or mitomycin within 6 weeks prior to the first dose of TKM-080301.
- Prior therapy with any biologic chemotherapeutic or investigational drug within 5 half-lives or 3 weeks, whichever is longer prior to the first dose of TKM 080301.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02191878
Start Date
June 1 2014
End Date
July 1 2016
Last Update
January 16 2019
Active Locations (15)
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1
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
2
University of California San Francisco
San Francisco, California, United States, 94115
3
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065