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

NCT00457782 | Completed Phase 1 DMC

• 1 other identifier: 2478-EU-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

Cancer; Blood disorders; Leukaemia, Adult Chronic; Lymphoma; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pharmacokinetics and Pharmacodynamics

  At baseline and steady state during cycle 1

Study Arms (1)

I

EXPERIMENTAL

Intravenous KW-2478 (ascending dose cohorts)

Drug: KW-2478

Interventions

KW-2478 DRUG

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

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead
• Kyowa Hakko Kirin UK, Ltd.: collaborator

Study Sites (6)

St Bartholomew's Hospital

London, United Kingdom

Location

UCLH

London, United Kingdom

Location

Christie Hospital

Manchester, United Kingdom

Location

Nottingham University NHS Trust

Nottingham, United Kingdom

Location

Cancer Research UK Clinical Centre

Southampton, United Kingdom

Location

Royal Marsden Hospital

Sutton, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma; Leukemia, B-Cell; Lymphoma, B-Cell; Neoplasms; Hematologic Diseases; Leukemia; Bronchiolitis Obliterans Syndrome; Lymphoma

Interventions

KW-2478

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Lymphatic Diseases; Lymphoma, Non-Hodgkin; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Study Officials

• Responsible Medical Officer KHKUK

  Kyowa Hakko Kirin UK

  STUDY DIRECTOR

• J D Cavenagh, MD. MRCP, MRCPath

  St Bartholomew's Hospital, London, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2007
• First Posted: April 6, 2007
• Study Start: April 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: January 1, 2011
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

GB (6)