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:
Kyowa Hakko Kirin UK, Ltd.
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
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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:
- 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
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 May 16, 2013