NCT00746590

Study of Anti-tumour Effects and Safety of Prolarix™ in Hepatocellular Carcinoma

A Phase 2 Study of the Anti-tumour Activity and Safety of Prolarix™ in Hepatocellular Carcinoma (HCC)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: BTG International Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This an open-label study designed to evaluate the anti-tumour activity and safety of Prolarix in subjects with advanced hepatocellular carcinoma. Prolarix is a chemotherapy comprised of tretazicar as prodrug and caricotamide as co-substrate for the endogenous enzyme, NQO2.

Detailed description

The primary objective of this study is to evaluate the anti-tumour effects of treatment with Prolarix in subjects with advanced HCC (Child-Pugh A and B only). All subjects will receive an IV infusion of Prolarix once every 21 days until disease progression is observed. Subjects will have CT scans for tumour measurements before starting treatment with Prolarix and every 6 weeks until disease progression. Subjects will undergo evaluation for safety (adverse events, vital signs, clinical laboratory measurements, weight, ECG) every 21 days until disease progression.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Prolarix (tretazicar co-administered with caricotamide)	Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-06-01
• Completion: 2009-08-01
• First posted: 2008-09-04
• Last updated: 2022-07-21
• Results posted: 2016-06-09

Locations

1 site across 1 country: Belgium