Spots Global Cancer Trial Database for Study of Anti-tumour Effects and Safety of Prolarix™ in Hepatocellular Carcinoma

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Trial Identification

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

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

Study ID: NCT00746590

Conditions

Hepatocellular Carcinoma

Interventions

Prolarix (tretazicar co-administered with caricotamide)

Study Description

Brief 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.