A Pilot Study of EZN-2968, an Antisense Oligonucleotide Inhibitor of HIF-1alpha, in Adults With Advanced Solid Tumors With Liver Metastases

• Status: Completed
• Trial end date: 2013-09-24

Summary

Background:

• A protein called HIF is believed to be involved both in forming cancers and helping them to grow after they are formed. EZN-2968 is a new type of cancer drug that goes into the cancer cell and switches off the production of the HIF protein. Researchers are interested in testing EZN-2968 in people who have liver cancer because studies have shown that this drug travels to the liver and stays there when the drug is given through a vein.

Objectives:

• To determine the safety and effectiveness of EZN-2968 on liver cancer.

Eligibility:

• Individuals 18 years of age and older who have been diagnosed with liver cancer that has not responded to standard treatments.

Design:

• Participants will have an initial screening visit with a physical examination, blood and urine tests, and imaging studies to assess tumor size. Tumor biopsies may also be taken for research purposes.

• Participants will have an undefined number of 6-week treatment cycles of EZN-2968, given once a week for 3 weeks followed by 3 weeks without the drug.

• During each cycle, participants will have additional blood tests and imaging scans to assess tumor response to treatment.

• Cycles of treatment with EZN-2968 may continue until the treatment is not effective, illness requires participants to stop taking the study drug, or the participant chooses to withdraw from the study.

• Phase: Phase 1

Details

• Lead Sponsor: National Cancer Institute (NCI)