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
  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
Lymphoma, B-Cell
Drug: KW-2478
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 27
Study Start Date: April 2007
Study Completion Date: January 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

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

Locations
United Kingdom
St Bartholomew's Hospital
London, United Kingdom
UCLH
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.
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: Study Director, Kyowa Hakko Kirin UK
ClinicalTrials.gov Identifier: NCT00457782     History of Changes
Other Study ID Numbers: 2478-EU-001
Study First Received: April 5, 2007
Last Updated: January 31, 2011
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

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

ClinicalTrials.gov processed this record on April 23, 2014