Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284804
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2006-01-30
Brief Title:
A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkins Disease
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
An Open-label Randomized Multicenter Phase II Study of MDX-060 in Combination With Gemcitabine MDX060 in Combination With Dexamethasone and Gemcitabine Monotherapy in Patients With Relapsed or Refractory Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2015-09
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 is designed to determine the objective response rate in patients with relapsed or refractory Hodgkins disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone
Detailed Description:
Secondary objectives include
to characterize progression-free survival
to characterize time to progression
to determine response duration
to characterize the effect of study drug on health-related quality of life
to explore the correlation of positron emission tomography PET scan results with objective responses observed with conventional imaging in this patient population
to characterize the immunogenicity response of MDX-060
to characterize the safety of MDX-060 and
to characterize the pharmacokinetic profile of MDX-060
to characterize progression-free survival
to characterize time to progression
to determine response duration
to characterize the effect of study drug on health-related quality of life
to explore the correlation of positron emission tomography PET scan results with objective responses observed with conventional imaging in this patient population
to characterize the immunogenicity response of MDX-060
to characterize the safety of MDX-060 and
to characterize the pharmacokinetic profile of MDX-060
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