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

NCT01063907 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2024-04-25

Study results available
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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).

Conditions

Interventions

DRUG

KW-2478

Administered Days 1, 4, 8 and 11 of a 21 day cycle

DRUG

Bortezomib

Administered on Days 1, 4, 8 and 11 of a 21 day cycle

Sponsors & Collaborators

  • Kyowa Hakko Kirin Pharma, Inc.

    collaborator INDUSTRY

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Michael Kurman, MD · Kyowa Hakko Kirin Pharma, Inc.

  • Loan Hoang-Sayag, MD · Quintiles, Inc.

  • Noel Pingoy, MD · Gleneagles CRC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States
  • Philippines
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01063907 on ClinicalTrials.gov