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 - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 5, 2007

Last Updated Date

February 12, 2009

Start Date ^†

April 2007

Current Primary Outcome Measures ^†

To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose [ Time Frame: At every visit and at the end of each 14-day treatment cycle ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00457782 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Pharmacokinetics and Pharmacodynamics [ Time Frame: At baseline and steady state during cycle 1 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^†

Multiple Myeloma
Chronic Lymphocytic Leukaemia
B-Cell Non-Hodgkin's Lymphoma

Intervention ^†

Drug: KW-2478

Study Arms / Comparison Groups

Experimental: Intravenous KW-2478 (ascending dose cohorts)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

December 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Patients with a confirmed diagnosis of Multiple Myeloma, Chronic Lymphocytic Leukaemia, or B-cell Non-Hodgkin's Lymphoma, who have had at least two prior standard treatment regimens and are without established therapeutic alternatives.
Signed IEC-approved informed consent
ECOG performance status of 0, 1 or 2;
Life expectancy of at least 3 months;
Adequate haematologic status, liver function and renal function
Patients of reproductive potential must agree to follow accepted birth control methods during the study

Exclusion Criteria:

No anti-cancer treatment for ≥ 3 weeks prior to receiving study drug
Any other severe, acute or chronic illness
No other prior or concurrent malignancy
Immunosuppressant therapy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Project Manager KHKUK

44(0)1 1753 566000

R&Dinfo@kyowa-kirin.co.uk

Location Countries ^†

United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00457782

Responsible Party

Study Director, Kyowa Hakko Kirin UK

Secondary IDs ^††

Study Sponsor ^†

Kyowa Hakko Kirin UK, Ltd.

Collaborators ^††

Investigators ^†

Study Director:	Responsible Medical Officer KHKUK	Kyowa Hakko Kirin UK
Principal Investigator:	J D Cavenagh, MD. MRCP, MRCPath	St Bartholomew's Hospital, London, UK

Information Provided By

Kyowa Hakko Kirin Pharma, Inc.

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.