Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065429
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2003-07-23
Brief Title:
Safety Study Using Weekly Infusions of BB-10901 in Patients With Small Cell Lung Cancer
Sponsor:
ImmunoGen Inc
Organization:
ImmunoGen Inc
Study Overview
Official Title:
A Phase I Open-Label Dose Escalation Study of Weekly Dosing With BB-10901 Followed by a Phase II Efficacy Expansion
Status:
COMPLETED
Status Verified Date:
2012-07
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 study was a Phase III trial primarily focused on efficacy of BB-10901 in relapsed small cell lung cancer and other solid tumors
Detailed Description:
The Phase II efficacy expansion was restricted to SCLC patients with relapsed disease and the MTD was determined by the Phase I portion of the trial 60mgm2
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