Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-07-13 @ 5:15 PM
Study NCT ID:
NCT00483093
Status:
COMPLETED
Last Update Posted:
2014-05-30
First Post:
2007-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of NGR-hTNF in Combination With Cisplatin in Solid Tumor
Sponsor:
AGC Biologics S.p.A.
Organization:
Study Overview
Official Title:
NGR004:A Phase IB Study of NGR-hTNF in Combination With Cisplatin in Patient Affected by Advanced or Metastatic Solid Tumor
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 safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of cisplatin, 80 mg/sqm). 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 not amenable of standard therapy will be enrolled.
Patients, with advanced or metastatic solid tumor not amenable of standard therapy will be enrolled.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2006-006035-42 | EUDRACT_NUMBER | None | View |