Ignite Creation Date:
2025-12-18 @ 6:58 AM
Ignite Modification Date:
2025-12-23 @ 10:48 PM
Study NCT ID:
NCT00746590
Status:
None
Last Update Posted:
2022-07-21 00:00:00
First Post:
2008-09-03 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Anti-tumour Effects and Safety of Prolarix™ in Hepatocellular Carcinoma
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase 2 Study of the Anti-tumour Activity and Safety of Prolarix™ in Hepatocellular Carcinoma (HCC)
Status:
None
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:
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.
Detailed Description:
None
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?: