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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-01-31

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.

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I

Intravenous KW-2478 (ascending dose cohorts)

Group Type EXPERIMENTAL

KW-2478

Intervention Type DRUG

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

Interventions

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KW-2478

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No