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

Kyowa Kirin Co., Ltd.27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

KW-2478DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

St Bartholomew's Hospital

London, United Kingdom

UCLH

London, United Kingdom

Christie Hospital

Manchester, United Kingdom

Nottingham University NHS Trust

Nottingham, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

Pharmacokinetics and Pharmacodynamics

Time frame: At baseline and steady state during cycle 1

Data from ClinicalTrials.gov

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