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 - Full Text View

Sponsored by:	Kyowa Hakko Kirin UK, Ltd.
Information provided by:	Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:	NCT00457782

Purpose

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	Intervention	Phase
Multiple Myeloma Chronic Lymphocytic Leukaemia B-Cell Non-Hodgkin's Lymphoma	Drug: KW-2478	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:

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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	54
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Intravenous KW-2478 (ascending dose cohorts)	Drug: KW-2478 Daily intravenous KW-2478 for 5 days in 14-day cycles, ascending dose cohorts

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457782

Contacts

Contact: Project Manager KHKUK

44(0)1 1753 566000

R&Dinfo@kyowa-kirin.co.uk

Locations

United Kingdom
St Bartholomew's Hospital	Recruiting
London, United Kingdom
Contact: J D Cavenagh, MD
UCLH	Recruiting
London, United Kingdom
Contact: Kwee Yong, MD
Nottingham University NHS Trust	Recruiting
Nottingham, United Kingdom
Contact: J Byrne, MD
Royal Marsden Hospital	Recruiting
Sutton, United Kingdom
Contact: G Morgan, MD
Cancer Research UK Clinical Centre	Recruiting
Southampton, United Kingdom
Contact: P Johnson, MD
Christie Hospital	Recruiting
Manchester, United Kingdom
Contact: J Cavet, MD

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

More Information

No publications provided

Responsible Party:	Kyowa Hakko Kirin UK ( Study Director )
Study ID Numbers:	2478-EU-001
Study First Received:	April 5, 2007
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00457782 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:

Cancer
Blood disorders
Leukaemia, Adult Chronic
Lymphoma
Multiple Myeloma

Study placed in the following topic categories:

Leukemia, Lymphoid
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Lymphoma, Small Cleaved-cell, Diffuse
Lymphoma, B-Cell
Leukemia

Lymphatic Diseases
Chronic Lymphocytic Leukemia
Hemorrhagic Disorders
B-cell Lymphomas
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, Chronic
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Leukemia, Lymphoid
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Hematologic Diseases
Blood Protein Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Lymphoma, B-Cell

Leukemia
Lymphatic Diseases
Neoplasms
Hemorrhagic Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Cardiovascular Diseases
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on September 02, 2009