Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484211
Status:
COMPLETED
Last Update Posted:
2014-05-30
First Post:
2007-06-07
Brief Title:
Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Hepatocellular Carcinoma HCC
Sponsor:
AGC Biologics SpA
Organization:
AGC Biologics SpA
Study Overview
Official Title:
NGR008 A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Advanced or Metastatic Hepatocellular Carcinoma HCC Previously Treated With no More Than One Systemic Therapeutic Regimen
Status:
COMPLETED
Status Verified Date:
2014-05
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:
The main objective of the trial is to document the progression free survival PFS in advanced or metastatic hepatocellular carcinoma patients treated with NGR-hTNF as single agent
Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria
Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria
Detailed Description:
This is a phase II open-label non-randomized study that will be conducted in patients affected by advanced or metastatic Hepatocellular Carcinoma HCC previously treated with no more than one systemic therapeutic regimen that will be conducted using Simons two-stage design method
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-005696-18 | EUDRACT_NUMBER | None | None |