Spots Global Cancer Trial Database for Study of GNS561 in Patients With Liver Cancer

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Trial Identification

Brief Title: Study of GNS561 in Patients With Liver Cancer

Official Title: Phase 1/2a Study to Evaluate the Safety, Activity, and Pharmacokinetics of Escalating Doses of GNS561 in Patients With Primary and Secondary Liver Cancer

Study ID: NCT03316222

Conditions

Hepatocellular Carcinoma

Cholangiocarcinoma, Intrahepatic

Interventions

GNS561

Study Description

Brief Summary: 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

Detailed Description: 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.