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 Relapsed/Refractory Multiple Myeloma, Chronic Lymphocytic Leukaemia or B-cell Non-Hodgkin's Lymphoma
This is a Phase I, open-label, dose-escalation study of KW-2478 in patients with
relapsed/refractory multiple myeloma, chronic lymphocytic leukaemia or B-cell Non-Hodgkin's
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose
At every visit and at the end of each 14-day treatment cycle
Yes
Responsible Medical Officer KHKUK
Study Director
Kyowa Hakko Kirin UK
United Kingdom: Medicines and Healthcare Products Regulatory Agency
2478-EU-001
NCT00457782
April 2007
January 2011
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