This is a first in human, open-label dose escalation study to investigate the safety,
tolerability and pharmacokinetics of GNS561 in patients Primary and Secondary liver cancer
This is a multicenter, open-label, uncontrolled, repeat-dose Phase 1/2a study designed to
evaluate the safety profile and to determine the recommended Phase 2 dose of GNS561 in
patients with advanced primary and secondary liver cancer. This study will enroll
approximately 50 patients and consists of 2 parts: Phase 1(dose escalation) and Phase 2
(expansion). All patients will be treated until the occurrence of an unacceptable toxicity,
disease progression, or withdrawal of consent. In this study a treatment cycle is defined as
4 weeks (28 days). Patients are to take their assigned dose of GNS561, in the Morning and in
the evening at the same time everyday, following a meal.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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