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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: KW-2478


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Intravenous KW-2478 (ascending dose cohorts) | Drug: KW-2478<br>* Daily intravenous KW-2478 for 5 days in 14-day cycles, ascending dose cohorts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics and Pharmacodynamics |  | At baseline and steady state during cycle 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Blood disorders, Leukaemia, Adult Chronic, Lymphoma, Multiple Myeloma