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

This study has been completed.

Sponsor:

Information provided by:

Kyowa Hakko Kirin Pharma, Inc.

ClinicalTrials.gov Identifier:

NCT00457782

First received: April 5, 2007

Last updated: January 31, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 5, 2007

Last Updated Date

January 31, 2011

Start Date ^ICMJE

April 2007

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

To determine Safety & Tolerability; To determine recommended Phase II dose

Change History

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

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Pharmacokinetics and Pharmacodynamics

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Myeloma
Chronic Lymphocytic Leukaemia
Lymphoma, B-Cell

Intervention ^ICMJE

Drug: KW-2478

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

Study Arm (s)

Experimental: I

Intravenous KW-2478 (ascending dose cohorts)

Intervention: Drug: KW-2478

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00457782

Other Study ID Numbers ^ICMJE

2478-EU-001

Has Data Monitoring Committee

Yes

Responsible Party

Study Director, Kyowa Hakko Kirin UK

Study Sponsor ^ICMJE

Kyowa Hakko Kirin UK, Ltd.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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