Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484341
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2007-06-07
Brief Title:
Phase II Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Soft Tissue Sarcomas
Sponsor:
AGC Biologics SpA
Organization:
AGC Biologics SpA
Study Overview
Official Title:
NGR016 Randomized Phase II Study Evaluating Two Doses of NGR-hTNF Administered Either as Single Agent or in Combination With Doxorubicin in Patients With Advanced Soft Tissue Sarcoma STS
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 preliminary antitumor activity of two doses of NGR-hTNF administered either alone or in combination with doxorubicin in locally advanced or metastatic soft-tissue sarcoma STS patients untreated or previously treated with one or more prior systemic regimen
Detailed Description:
Considering the safetytoxicity profile of NGR-hTNF characterized by mild-to-moderate constitutional symptoms when given either every three weeks or weekly both at low 08 µgm2 and high dose 45 µgm2 the reversibility of these adverse events generally occurring only during the infusion time the absence of overlapping toxicities with chemotherapeutic agents and the safety and preliminary antitumor activity observed in phase Ib trial with doxorubicin seems justified to evaluate in a randomized 4-arm phase II trial the preliminary antitumor activity of two doses of NGR-hTNF 08 µgm2 and 45 µgm2 administered weekly either alone or in combination with a standard dose of doxorubicin 60 mgm2 every three weeks
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 |
|---|---|---|---|
| 2010-018851-88 | EUDRACT_NUMBER | None | None |