Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080015
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
2004-03-19
Brief Title:
Diflomotecan BN80915 Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer SCLC
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
A Phase II Open Label Study Investigating the Activity of Diflomotecan BN80915 Administered at the Fixed Dose of 7mg as a 20 Minute Intravenous Infusion Once Every 3 Weeks in Patients With Sensitive Small Cell Lung Cancer SCLC Who Have Failed First-line Treatment With a Platinum Based Regimen
Status:
COMPLETED
Status Verified Date:
2020-04
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:
This is a Phase II open-label multicenter single-arm exploratory proof of concept study Diflomotecan 7 mg fixed dose will be administered as a 20-minute IV infusion once every 3 weeks in patients with sensitive small cell lung cancer SCLC with progressive disease after first-line treatment with a platinum-based regimen
Detailed Description:
None
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 |
|---|---|---|---|
| 2004-001350-92 | EUDRACT_NUMBER | None | None |