NCT03316222

Study of GNS561 in Patients With Liver Cancer

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Genoscience Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma
• Cholangiocarcinoma, Intrahepatic

Interventions

Type	Name	Description
DRUG	GNS561	Escalating doses to be administered 3 times a week.

Timeline

• Start date: 2018-04-04
• Primary completion: 2021-01-15
• Completion: 2022-04-25
• First posted: 2017-10-20
• Last updated: 2022-05-02

Locations

5 sites across 3 countries: United States, Belgium, France

Regulatory

• FDA-regulated drug study