Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051584
Status:
TERMINATED
Last Update Posted:
2011-10-24
First Post:
2003-01-13
Brief Title:
SafetyEfficacy Study of SGN-15 Antibody-Drug Conjugate Combined With Gemcitabine in Patients With Ovarian Cancer
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Phase II Study of SGN-15 cBR96 - Doxorubicin Immunoconjugate Combined With Gemzar Versus Single-Agent Gemzar in Patients With Advanced Ovarian Cancer
Status:
TERMINATED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label randomized phase II trial comparing treatment with a monoclonal antibody mAb drug immunoconjugate SGN-15 administered weekly in combination with weekly Gemzar Gemcitabine to treatment with Gemzar alone The primary objectives of this study are to determine the toxicity and safety profile of the combination of SGN-15 and Gemzar to estimate the clinical response rate and to estimate the duration of response of this combination therapy administered to patients with advanced ovarian cancer compared to treatment with Gemzar alone
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