Ignite Creation Date:
2024-05-05 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00746317
Status:
COMPLETED
Last Update Posted:
2012-10-17
First Post:
2008-09-01
Brief Title:
A Phase I Study of GC33 in Advanced or Metastatic Liver Cancer Hepatocellular Carcinoma
Sponsor:
Chugai Pharmaceutical
Organization:
Chugai Pharmaceutical
Study Overview
Official Title:
A Phase I Open-Label Multi-center Dose-escalation Study of the Safety Tolerability and Pharmacokinetics of GC33 Administered Weekly in Patients With Advanced or Metastatic Hepatocellular Carcinoma HCC
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial is studying the safety and best dose of GC33 in patients with advanced or metastatic liver cancer
Detailed Description:
This is a Phase I open-label dose escalation study of GC33 in patients with advanced or metastatic HCC This study is designed to evaluate safety tolerability pharmacokinetics and preliminary assessment of anti-tumor activity Enrollment will proceed until a maximum tolerated dose MTD and a recommended Phase II dose has been established
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