Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484432
Status:
COMPLETED
Last Update Posted:
2018-09-27
First Post:
2007-06-07
Brief Title:
Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Ovarian Cancer
Sponsor:
AGC Biologics SpA
Organization:
AGC Biologics SpA
Study Overview
Official Title:
NGR012 A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2018-08
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 response rate in patients affected by metastatic ovarian cancer treated with NGR-hTNF plus doxorubicin Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria
Detailed Description:
This is a phase II open-labelsingle arm non-randomized study that will be conducted in patients affected by metastatic ovarian cancer 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 |
|---|---|---|---|
| 2007-000004-33 | EUDRACT_NUMBER | None | None |