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:
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

April 5, 2007
January 31, 2011
April 2007
August 2010   (final data collection date for primary outcome measure)
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 ]
To determine Safety & Tolerability; To determine recommended Phase II dose
Complete list of historical versions of study NCT00457782 on ClinicalTrials.gov Archive Site
Pharmacokinetics and Pharmacodynamics [ Time Frame: At baseline and steady state during cycle 1 ] [ Designated as safety issue: No ]
Pharmacokinetics and Pharmacodynamics
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Myeloma
  • Chronic Lymphocytic Leukaemia
  • Lymphoma, B-Cell
Drug: KW-2478
Daily intravenous KW-2478 for 5 days in 14-day cycles, ascending dose cohorts
Experimental: I
Intravenous KW-2478 (ascending dose cohorts)
Intervention: Drug: KW-2478
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
January 2011
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00457782
2478-EU-001
Yes
Study Director, Kyowa Hakko Kirin UK
Kyowa Hakko Kirin UK, Ltd.
Not Provided
Study Director: Responsible Medical Officer KHKUK Kyowa Hakko Kirin UK
Principal Investigator: J D Cavenagh, MD. MRCP, MRCPath St Bartholomew's Hospital, London, UK
Kyowa Hakko Kirin Pharma, Inc.
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP