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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin UK, Ltd.

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