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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-Hodgkin's Lymphoma
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 Relapsed/Refractory Multiple Myeloma, Chronic Lymphocytic Leukaemia or B-cell Non-Hodgkin's Lymphoma
Study ID: NCT00457782
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 relapsed/refractory MM, CLL or B-cell NHL.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
St Bartholomew's Hospital, London, , United Kingdom
UCLH, London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Nottingham University NHS Trust, Nottingham, , United Kingdom
Cancer Research UK Clinical Centre, Southampton, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
Name: Responsible Medical Officer KHKUK
Affiliation: Kyowa Hakko Kirin UK
Role: STUDY_DIRECTOR
Name: J D Cavenagh, MD. MRCP, MRCPath
Affiliation: St Bartholomew's Hospital, London, UK
Role: PRINCIPAL_INVESTIGATOR