Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00457782
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2007-04-05
Brief Title:
A Phase I Safety PK and PD Study of KW-2478 in Patients With Multiple Myeloma Chronic Lymphocytic Leukaemia or B-cell Non-Hodgkins Lymphoma
Sponsor:
Kyowa Kirin Co Ltd
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
A Phase I Open-Label Dose-escalation Multicentre Study of KW-2478 Administered as a Single Agent Intravenously in a Consecutive Dosing Schedule in Patients With RelapsedRefractory Multiple Myeloma Chronic Lymphocytic Leukaemia or B-cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2024-04
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:
The aim of this study is to determine the safety tolerability and dose-limiting toxicities of KW-2478 and to determine the Maximum Tolerated Dose and recommended Phase II dose for patients with relapsedrefractory MM CLL or B-cell NHL
Detailed Description:
This is a Phase I open-label dose-escalation study of KW-2478 in patients with relapsedrefractory multiple myeloma chronic lymphocytic leukaemia or B-cell Non-Hodgkins lymphoma who have no established therapeutic alternatives Up to 42 patients will be enrolled at up to six investigational sites over a period of approximately 12 months until an MTD is reached An additional 12 patients may be enrolled at the MTD in an expanded cohort of one or more of the eligible conditions
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