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Completed

NCT Number: NCT00457782

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 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.

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Key information

Conditions

Multiple Myeloma B-cell Non-Hodgkin's Lymphoma Blood Protein Disorders Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Cardiovascular Diseases Chronic Lymphocytic Leukaemia Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphoid Lung Diseases Lung Diseases, Obstructive Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Organizing Pneumonia Paraproteinemias Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St Bartholomew's Hospital, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KW-2478

Drug

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

Primary outcomes

  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 outcomes

  1. Pharmacokinetics and Pharmacodynamics

    Time frame: At baseline and steady state during cycle 1

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Collaborators

  • Kyowa Hakko Kirin UK, Ltd.

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Apr 6, 2007
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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