Clinical trial NCT00457782: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Chronic Lymphocytic Leukaemia
B-cell Non-Hodgkin's Lymphoma
Keywords: Cancer
Blood disorders
Leukaemia, Adult Chronic
Lymphoma
Multiple Myeloma
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Hakko Kirin UK, Ltd.
First posted: 2007-04-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 criteria: 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

Primary outcomes:
measure: To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose
timeFrame: At every visit and at the end of each 14-day treatment cycle
Secondary outcomes:
measure: Pharmacokinetics and Pharmacodynamics
timeFrame: At baseline and steady state during cycle 1
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: UCLH
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University NHS Trust
city: Southampton
country: United Kingdom
facility: Cancer Research UK Clinical Centre
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Kyowa Hakko Kirin UK
name: Responsible Medical Officer KHKUK
role: STUDY_DIRECTOR
affiliation: St Bartholomew's Hospital, London, UK
name: J D Cavenagh, MD. MRCP, MRCPath
role: PRINCIPAL_INVESTIGATOR
References: