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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kyowa Hakko Kirin Company, Limited
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01063907
First received: February 4, 2010
Last updated: April 4, 2014
Last verified: April 2014
  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:


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 ]

Enrollment: 95
Study Start Date: March 2010
Estimated Study Completion Date: April 2014
Primary Completion Date: December 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:

  1. 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.
  2. Signed either an IRB or IEC approved informed consent
  3. ECOG performance status of ≤ 2
  4. Life expectancy of at least 3 months
  5. 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
  6. Adequate hematologic status, liver and renal function
  7. Subjects of reproductive potential must agree to follow accepted pregnancy prevention methods during the study.

Exclusion Criteria:

  1. No anti-cancer treatment for ≥ 4 weeks and no bortezomib treatment ≥ 60 days prior to receiving study drug
  2. Any other severe, acute or chronic illness
  3. No other prior or concurrent malignancy
  4. No immunosuppressant therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Arizona Clinical Research Center, Inc. / Arizona Oncology Associates, 1825 N Kolb,
Tucson, Arizona, United States, 85715
United States, California
Pacific Shores Medical Group 1043 Elm Ave, Suite 104
Long Beach, California, United States, 90813
UCLA Medical Center Hematology / Oncology Division, 10945 Le Conte Ave #2333,
Los Angeles, California, United States, 90095-7059
United States, Florida
Collaborative Research Group 2320 S Seacrest Blvd, Suite 202
Boynton Beach, Florida, United States, 33435
United States, Illinois
Rush University Medical Center / Division of Hematology/Oncology Research 1725 W Harrison Street, Suite 834
Chicago, Illinois, United States, 60612
United States, New Jersey
Cancer Institute of New Jersey 195 Little Albany Street
New Brunswick, New Jersey, United States, 08903-2681
United States, Tennessee
The Jones Clinic 7710 Wolf River Circle
Germantown, Tennessee, United States, 38138
United States, Texas
UT MD Anderson Cancer Center, 1515 Holcombe Boulevard,
Houston, Texas, United States, 77030
United States, Wisconsin
Gundersen Clinic Center for Cancer and Blood Disorders, 1900 South Ave, EB2-001,
La Crosse, Wisconsin, United States, 54601
Philippines
National Kidney and Transplant Institute, Rm 3215 Doctors Clinic, East Avenue
Diliman, Quezon City, Philippines
Makati Medical Center, New Wing Hall C372, #2 Amorsolo Street, Legaspi Village,
Makati City, Philippines
The Medical City, 1609 MATI Building, The Medical City, Ortigas Avenue,
Pasig City, Metro Manila, Philippines
Saint Lukes Medical Center, Rm 222 MAB Saint Lukes Medical Center, E. Rodriguez
Quezon City, Philippines
United Kingdom
Darent Valley Hospital Dept of Haematology, Acorn House, Darenth Wood Road
Dartford, Kent, United Kingdom, DA2 8DA
St Bartholomew's Hospital Haematology Department, 1st Floor, Pathology
Dominion House, 59 Bartholomew Close, London, United Kingdom, EC1 7ED
Christie Hospital - Department Haematology, 550 Wilmslow Road
Withington, Manchester, Greater Manchester, United Kingdom, M20 4BX
Hillingdon Hospital Dept of Haematology, Pield Health Road
Uxbridge, Middlesex, United Kingdom, UB8 3NN
Nottingham University Hospitals NHS Trust, Centre for Clinical Haemotology
Hucknall Road, Nottingham, United Kingdom, NG5 1PB
Royal Marsden Hospital, Orchard House
Downs Road, Sutton, Surrey, United Kingdom, SM2 5PT
Royal Bournemouth Hospital, Dept. of Haematolgy, Castle Lane East,
Bournemouth, United Kingdom, BH7 7DW
Royal Devon & Exeter Hospital Haematology Centre, Barrack Road
Exeter, United Kingdom, EX2 5DW
Northwick Park Hospital Dept of Haematology, Watford Road
Harrow, United Kingdom, HA1 3UJ
St James Hospital, St James' Institute of Oncology, Department of Haematology, Level 03, Bexley Wing,
Leeds, United Kingdom, LS9 7TF
UCL Cancer Institute, Paul O'Gorman Building, University College London,72 Huntley Street
London, United Kingdom, WC1E 6DD
Manchester Royal Infirmary Dept of Haematology, Oxford Road
Manchester, United Kingdom, M13 9WL
Royal Cornwall Hospital Haematology Clinic
Truro, United Kingdom, TR1 3LS
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: Noel Pingoy, 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, 2009-016223-56
Study First Received: February 4, 2010
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Philippines : Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014