A Phase I/II Study of TKM-080301in Patients with Advanced Liver Cancer

Full Title

An Open-Label, Multi-Center, Phase 1, Dose Escalation Study With Phase 2 Expansion Cohort to Determine the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Intravenous TKM-080301 in Subjects With Advanced Hepatocellular Carcinoma

Purpose

The purpose of this study is to find the highest dose of the investigational drug TKM-080301that can be given safely in patients with advanced hepatocellular carcinoma (a type of liver cancer). TKM-080301 works by reducing levels of a protein called PLK1, which is present at high levels in dividing cancer cells. It is hoped that by reducing PLK1, TKM-080301 can prevent liver cancer cells from dividing.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced liver cancer that cannot be cured by surgery, transplant, or radiofrequency ablation.
  • Patients must recover from the serious side effects of previous therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Ghassan Abou-Alfa at 646-888-4184.

Protocol

14-241

Phase

I/II

Investigator

Co-Investigators

Locations