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

Sponsor:	Kyowa Hakko Kirin Pharma, Inc.
Collaborator:	Kyowa Hakko Kirin Company, Limited
Information provided by (Responsible Party):	Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:	NCT01063907

Purpose

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).

Condition	Intervention	Phase
Multiple Myeloma	Drug: KW-2478 and bortezomib	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label, Dose Escalation, Multicenter Phase 1/2 Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Leukemia Multiple Myeloma

Drug Information available for: Bortezomib

U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:

Primary Outcome Measures:

The primary objectives: To establish the safety, tolerability, and RP2D (Phase I); To assess the overall response rate in subjects with advanced Multiple Myeloma (Phase II). [ Time Frame: 21 day cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary objectives: To characterize the PK and PD (Phase I); To evaluate for preliminary efficacy (Phase I); To determine progression free survival and duration of response Phase II. [ Time Frame: 21 day cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	101
Study Start Date:	March 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: KW-2478 and bortezomib	Drug: KW-2478 and bortezomib KW 2478 and bortezomib given on Days 1, 4, 8 and 11 of a 21 day cycle Other Names: Velcade HSP90 Inhibitor

Detailed 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. Centers in the Philippines will be participating in Phase II only. The planned enrollment period is 22 months and the planned study duration is 28 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Accepts Healthy Volunteers: No

Inclusion Criteria:

Subjects with a confirmed diagnosis of Multiple Myeloma who have had one and no more than three prior regimens for MM to which they did not respond (failed) or from which they have relapsed.
Signed either an IRB or IEC approved informed consent
ECOG performance status of ≤ 2
Life expectancy of at least 3 months
M protein in either serum or urine, or free light chains if not measurable M protein in serum or urine, and clonal bone marrow plasma cells > 10%, and evidence of end organ damage
Adequate hematologic status, liver and renal function
Subjects of reproductive potential must agree to follow accepted pregnancy prevention methods during the study.

Exclusion Criteria:

No anti-cancer treatment for ≥ 4 weeks and no bortezomib treatment ≥ 60 days prior to receiving study drug
Any other severe, acute or chronic illness
No other prior or concurrent malignancy
No immunosuppressant therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063907

Show 30 Study Locations

Sponsors and Collaborators

Kyowa Hakko Kirin Pharma, Inc.

Kyowa Hakko Kirin Company, Limited

Investigators

Study Director:	Michael Kurman, MD	Kyowa Hakko Kirin Pharma, Inc.
Study Chair:	Loan Hoang-Sayag, MD	Quintiles UK
Study Chair:	Marife Mararang, MD	Gleneagles CRC

More Information

No publications provided

Responsible Party:	Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:	NCT01063907 History of Changes
Other Study ID Numbers:	2478-INT-001
Study First Received:	February 4, 2010
Last Updated:	April 9, 2012
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:

Leukemia
Immunoproliferative Disorder
Neoplasma by Histologic Type
Immune System Diseases
Hematologic Diseases
Blood Protein Disorders
Paraproteinemias

Multiple Myeloma
Hematologic Disorders
Leukemia, Chronic, B-cell
Leukemia, B-cell
Leukemia, Chronic
Neoplasms, Plasma Cell
Monoclonal Gammopathy of unknown significance (MGUS)

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2012