Ignite Creation Date:
2024-05-05 @ 9:51 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00976170
Status:
COMPLETED
Last Update Posted:
2014-10-03
First Post:
2009-09-09
Brief Title:
Study of GC33 and Sorafenib in Combination 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 in Combination With Sorafenib Nexavar in Patients With Advanced or Metastatic Hepatocellular Carcinoma HCC
Status:
COMPLETED
Status Verified Date:
2014-10
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 and Sorafenib in combination in patients with advanced or metastatic liver cancer
Detailed Description:
This is a Phase I open-label dose escalation study of GC33 in combination with Sorafenib in patients with advanced or metastatic HCC This study is designed to evaluate safety tolerability pharmacokinetics and efficacy 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