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

Phase 1

Completed

• Conditions: Multiple Myeloma; Chronic Lymphocytic Leukaemia; B-cell Non-Hodgkin's Lymphoma
• Interventions: Drug: KW-2478

• Registration Number: NCT00457782
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-06
• Primary Completion: 2010-08
• Study Completion: 2011-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I	KW-2478	Intravenous KW-2478 (ascending dose cohorts)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pharmacokinetics and Pharmacodynamics	At baseline and steady state during cycle 1

Trial Locations

Locations (6)

Christie Hospital; 🇬🇧 Manchester, United Kingdom

Nottingham University NHS Trust; 🇬🇧 Nottingham, United Kingdom

St Bartholomew's Hospital; 🇬🇧 London, United Kingdom

UCLH; 🇬🇧 London, United Kingdom

Royal Marsden Hospital; 🇬🇧 Sutton, United Kingdom

Cancer Research UK Clinical Centre; 🇬🇧 Southampton, United Kingdom