Trial intelligence / Profile preview

Enzastaurin in previously treated WM or MM

NCT00718419Phase 2

Key facts

Status
Completed
Start
Jul 2008
Primary completion
Sep 2010
Countries
2
Modality
Small Molecules
Conditions
Waldenstrom macroglobulinemia (WM)multiple myeloma (MM)
01

Overview

Phase 2, open-label, single-arm trial of enzastaurin in Waldenstrom macroglobulinemia (WM) and multiple myeloma (MM), sponsored by Eli Lilly and Company. Primary endpoint: Percentage of Participants With Complete Response (CR), Partial Response (PR) and Minimal Response (MR) or Minor Response (MinR) up to 40.51 months. Started Jul 2008; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Enzastaurin

    Single-agent Enzastaurin

03

Who it enrols

Patients with previously treated Waldenstrom's Macroglobulinemia or Multiple Myeloma (1-5 prior therapies) with adequate organ function and no prior allogeneic transplant.

04

Endpoints

Primary

  • Percentage of Participants With Complete Response (CR), Partial Response (PR) and Minimal Response (MR) or Minor Response (MinR)

Secondary

  • Duration of Response

  • Time to Progressive Disease

  • Number of Participants With Adverse Events

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