Ignite Creation Date:
2024-05-05 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00746590
Status:
TERMINATED
Last Update Posted:
2022-07-21
First Post:
2008-09-03
Brief Title:
Study of Anti-tumour Effects and Safety of Prolarix in Hepatocellular Carcinoma
Sponsor:
BTG International Inc
Organization:
BTG International Inc
Study Overview
Official Title:
A Phase 2 Study of the Anti-tumour Activity and Safety of Prolarix in Hepatocellular Carcinoma HCC
Status:
TERMINATED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated prematurely by sponsor for business reason One patient was enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None