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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457782
• Other study ID #: 2478-EU-001
• Status: Completed
• Phase: Phase 1
• Start date: April 2007
• Est. completion date: January 2011

Study information

• Verified date: April 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• B-cell Non-Hodgkin's Lymphoma
• Chronic Lymphocytic Leukaemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.	Kyowa Hakko Kirin UK, Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose		At every visit and at the end of each 14-day treatment cycle
Secondary	Pharmacokinetics and Pharmacodynamics		At baseline and steady state during cycle 1