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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Interventions

KW-2478

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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