Status:
COMPLETED
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
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Collaborating Sponsors:
Kyowa Hakko Kirin UK, Ltd.
Conditions:
Multiple Myeloma
Chronic Lymphocytic Leukaemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 relap...
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 establ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00457782
Start Date
April 1 2007
End Date
January 1 2011
Last Update
April 25 2024
Active Locations (6)
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1
St Bartholomew's Hospital
London, United Kingdom
2
UCLH
London, United Kingdom
3
Christie Hospital
Manchester, United Kingdom
4
Nottingham University NHS Trust
Nottingham, United Kingdom