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A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma

2014-08-27 03:16:07 | BioPortfolio

Summary

The purpose of this study is to assess the safety and benefits of the investigational study drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of Multiple Myeloma (MM).

The primary objectives:

- To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478 in combination with bortezomib (Phase I);

- To assess the overall response rate (ORR) when subjects with advanced MM are treated (Phase II).

The secondary objectives:

- To characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of KW-2478 with bortezomib (Phase I only);

- To evaluate for preliminary evidence of efficacy (Phase I);

- To determine progression free survival (PFS) and duration of response of KW-2478 with bortezomib (Phase II).

Description

This is a multicenter, open label, dose escalation, Phase I / II study in subjects with relapsed and/or refractory MM. Up to 24 subjects to be enrolled in the Phase I to determine the RP2D. Up to 77 additional evaluable subjects to be enrolled in Phase II for a maximum up to 101 subjects treated in the study. Study centers in the USA and the UK will participate in Phase I and II. The planned enrollment period is 22 months and the planned study duration is 28 months.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Multiple Myeloma

Intervention

KW-2478 and bortezomib

Location

Arizona Clinical Research Center, Inc. / Arizona Oncology Associates
1825 N Kolb, Tucson
Arizona
United States
85715

Status

Recruiting

Source

Kyowa Hakko Kirin Pharma, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:07-0400

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