Study of Anti-tumour Effects and Safety of Prolarix™ in Hepatocellular Carcinoma
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.
|Hepatocellular Carcinoma||Drug: Prolarix (tretazicar co-administered with caricotamide)||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of the Anti-tumour Activity and Safety of Prolarix™ in Hepatocellular Carcinoma (HCC)|
- Overall Best Tumor Response Rate (Proportion of Subjects With Complete or Partial Response) as Defined by Modified RECIST [ Time Frame: every 6 weeks until progression ]
- Disease Control Rate Defined as the Proportion of Subjects With Either Complete or Partial Response or Stable Disease [ Time Frame: Approximately 12 weeks or more after first treatment with Prolarix ]
- Time to Tumour Progression [ Time Frame: Every 3 weeks until progression ]
- Post-treatment Changes in the Amount of Contrast-enhancing and Non-contrast-enhancing Tumour [ Time Frame: Every 6 weeks until progression ]
- Changes in Alpha Fetoprotein [ Time Frame: Baseline, every 3 weeks until progression ]
- Adverse Events [ Time Frame: Until progression ]
- Changes in Laboratory Measurements [ Time Frame: Baseline and every 3 weeks until progression ]
|Study Start Date:||September 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
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
Other Name: Prolarix
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746590
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Study Director:||Claire Daugherty, MS||BTG International Inc.|