Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Intravenous TKM-080301 in Subjects With Advanced Hepatocellular Carcinoma
Completed · Phase 1/Phase 2
Conditions studied: Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Adult
In brief
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 TKM-080301 in subjects with advanced hepatocellular carcinoma (HCC). This study is being done to: * Test the safety and tolerability of TKM-080301 in subjects with advanced hepatocellular carcinoma * Find the highest dose of TKM-080301 that can be given without causing side effects, called the maximum tolerated dose (MTD). * Provide a preliminary assessment of anti-tumor activity of TKM-080301
Key facts
- Study ID
- NCT02191878
- Run by
- Arbutus Biopharma Corporation
- People needed
- 43
- Starts
- 2014-06-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2019-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arizona Clinical Research Center — Tucson, Arizona, United States
- University of California San Francisco — San Francisco, California, United States
- Kansas City Research Institute — Kansas City, Missouri, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Mary Crowley Cancer Research Centers — Dallas, Texas, United States
- Princess Margaret Hospital — Toronto, Ontario, Canada
- Queen Mary Hospital — Hong Kong, China
- National University Hospital — Singapore, Singapore
- Seoul National University Hospital — Seoul, Gyeonggi-do, South Korea
- Samsung Medical Center — Seoul, Gyeonggi-do, South Korea
- ASAN Medical Center — Seoul, Gyeonggi-do, South Korea
- Severence Hospital, Yonsei, University Health System — Seoul, South Korea
- National Taiwan University Hospital — Taipei, Taiwan
- Taipei Medical University Hospital, Shuang-Ho Hospital — Taipei, Taiwan
- Taipei Veterans General Hospital — Taipei, Taiwan
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.