Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305084
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2006-03-15
Brief Title:
Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors
Sponsor:
AGC Biologics SpA
Organization:
AGC Biologics SpA
Study Overview
Official Title:
A Phase IB Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Solid Tumors
Status:
COMPLETED
Status Verified Date:
2019-09
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 safety of the combination escalation doses of NGR-hTNF from 02 mcgsqm to 16 mcgsqm with a fixed dose of doxorubicin 75 mgsqm Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria NCI-CTC
Detailed Description:
This is a phase IB open-label non-randomized dose-escalation study that will be conducted in sequential cohorts of patients Three patients per each cohort are planned
Patients with advanced or metastatic solid tumor previously treated with a non cumulative dose of doxorubicin 300 mgsqm in order to allow an adequate number of cycles or chemotherapy naïve will be enrolled
Patients with advanced or metastatic solid tumor previously treated with a non cumulative dose of doxorubicin 300 mgsqm in order to allow an adequate number of cycles or chemotherapy naïve will be enrolled
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 |
|---|---|---|---|
| EUDRACT Number 2005-004846-15 | None | None | None |