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

Sponsor

Kyowa Hakko Kirin UK, Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT00457782

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Chronic Lymphocytic Leukaemia B-cell Non-Hodgkin's Lymphoma	Drug: KW-2478	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I Intravenous KW-2478 (ascending dose cohorts)	Drug: KW-2478 Daily intravenous KW-2478 for 5 days in 14-day cycles, ascending dose cohorts

Arm

Intervention/Treatment

Experimental: I

Intravenous KW-2478 (ascending dose cohorts)

Drug: KW-2478

Daily intravenous KW-2478 for 5 days in 14-day cycles, ascending dose cohorts

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Pharmacokinetics and Pharmacodynamics [At baseline and steady state during cycle 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	St Bartholomew's Hospital	London	United Kingdom
2	UCLH	London	United Kingdom
3	Christie Hospital	Manchester	United Kingdom
4	Nottingham University NHS Trust	Nottingham	United Kingdom
5	Cancer Research UK Clinical Centre	Southampton	United Kingdom
6	Royal Marsden Hospital	Sutton	United Kingdom

Sponsors and Collaborators

Kyowa Hakko Kirin UK, Ltd.

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