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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00457782
Recruitment Status : Completed
First Posted : April 6, 2007
Last Update Posted : February 1, 2011
Information provided by:
Kyowa Kirin Pharmaceutical Development, Inc.

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 Type : Interventional  (Clinical Trial)
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 : April 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : January 2011

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetics and Pharmacodynamics [ Time Frame: At baseline and steady state during cycle 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Signed IEC-approved informed consent
  3. ECOG performance status of 0, 1 or 2;
  4. Life expectancy of at least 3 months;
  5. Adequate haematologic status, liver function and renal function
  6. Patients of reproductive potential must agree to follow accepted birth control methods during the study

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00457782

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

Responsible Party: Study Director, Kyowa Hakko Kirin UK Identifier: NCT00457782     History of Changes
Other Study ID Numbers: 2478-EU-001
First Posted: April 6, 2007    Key Record Dates
Last Update Posted: February 1, 2011
Last Verified: January 2011

Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc.:
Blood disorders
Leukaemia, Adult Chronic
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, B-Cell