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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

Primary Purpose

Multiple Myeloma, Chronic Lymphocytic Leukaemia, B-cell Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
KW-2478
Sponsored by
Kyowa Hakko Kirin UK, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Cancer, Blood disorders, Leukaemia, Adult Chronic, Lymphoma, Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Bartholomew's Hospital
  • UCLH
  • Christie Hospital
  • Nottingham University NHS Trust
  • Cancer Research UK Clinical Centre
  • Royal Marsden Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I

Arm Description

Intravenous KW-2478 (ascending dose cohorts)

Outcomes

Primary Outcome Measures

To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose

Secondary Outcome Measures

Pharmacokinetics and Pharmacodynamics

Full Information

First Posted
April 5, 2007
Last Updated
January 31, 2011
Sponsor
Kyowa Hakko Kirin UK, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00457782
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kyowa Hakko Kirin UK, Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Chronic Lymphocytic Leukaemia, B-cell Non-Hodgkin's Lymphoma
Keywords
Cancer, Blood disorders, Leukaemia, Adult Chronic, Lymphoma, Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Intravenous KW-2478 (ascending dose cohorts)
Intervention Type
Drug
Intervention Name(s)
KW-2478
Intervention Description
Daily intravenous KW-2478 for 5 days in 14-day cycles, ascending dose cohorts
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Pharmacokinetics and Pharmacodynamics
Time Frame
At baseline and steady state during cycle 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Responsible Medical Officer KHKUK
Organizational Affiliation
Kyowa Hakko Kirin UK
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
J D Cavenagh, MD. MRCP, MRCPath
Organizational Affiliation
St Bartholomew's Hospital, London, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Bartholomew's Hospital
City
London
Country
United Kingdom
Facility Name
UCLH
City
London
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
Country
United Kingdom
Facility Name
Nottingham University NHS Trust
City
Nottingham
Country
United Kingdom
Facility Name
Cancer Research UK Clinical Centre
City
Southampton
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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