Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199342
Status:
TERMINATED
Last Update Posted:
2024-05-03
First Post:
2005-09-12
Brief Title:
A Study of a Monoclonal Antibody KW-2871 in Patients With Advanced Melanoma
Sponsor:
Kyowa Kirin Inc
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
An Open-Label Study of KW-2871 Administered With a Premedication Regimen in Patients With Advanced Stage IV Melanoma
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Occurrence of 2 dose-limiting toxicities at the initial dose level 60 mgm2 in Part I
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a dose escalating cohort study to determine the maximum tolerated dose MTD of KW-2871 in dose cohorts of 60 80 and 100 mgm2 when administered with a specified premedication regimen ranitidine diphenhydramine and dexamethasone KW-2871 will be administered at 14-day intervals
Detailed Description:
This open label study consists of two parts Part I the Phase I component of the study will be conducted at a single center and will enroll up to 18 patients with histologically documented Stage IV melanoma per the American Joint Committee on Cancer AJCC criteria that is not currently amenable to surgical resection or other therapies
A specified premedication regimen consisting of ranitidine diphenhydramine and dexamethasone will be administered to all patients 30 minutes prior to infusion of any dose of KW-2871
Planned doses of KW-2871 are 60 mgm2 80 mgm2 100 mgm2
After identification of the MTD 30 patients will be enrolled at that dose level in Part II of the study If no MTD is identified after treatment with the 100 mgm2 dose level the dose administered in Part II of the study will be 100 mgm2 If the MTD is determined as 60 mgm2 this study will be closed to further patient accrual and will not proceed to Part II
A specified premedication regimen consisting of ranitidine diphenhydramine and dexamethasone will be administered to all patients 30 minutes prior to infusion of any dose of KW-2871
Planned doses of KW-2871 are 60 mgm2 80 mgm2 100 mgm2
After identification of the MTD 30 patients will be enrolled at that dose level in Part II of the study If no MTD is identified after treatment with the 100 mgm2 dose level the dose administered in Part II of the study will be 100 mgm2 If the MTD is determined as 60 mgm2 this study will be closed to further patient accrual and will not proceed to Part II
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