Spots Global Cancer Trial Database for A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
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Trial Identification
Brief Title: A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
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
Study ID: NCT01063907
Conditions
Study Description
Brief 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).
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Clinical Research Center, Inc. / Arizona Oncology Associates, 1825 N Kolb,, Tucson, Arizona, United States
Pacific Shores Medical Group 1043 Elm Ave, Suite 104, Long Beach, California, United States
UCLA Medical Center Hematology / Oncology Division, 10945 Le Conte Ave #2333,, Los Angeles, California, United States
Collaborative Research Group 2320 S Seacrest Blvd, Suite 202, Boynton Beach, Florida, United States
Rush University Medical Center / Division of Hematology/Oncology Research 1725 W Harrison Street, Suite 834, Chicago, Illinois, United States
Cancer Institute of New Jersey 195 Little Albany Street, New Brunswick, New Jersey, United States
The Jones Clinic 7710 Wolf River Circle, Germantown, Tennessee, United States
UT MD Anderson Cancer Center, 1515 Holcombe Boulevard,, Houston, Texas, United States
Gundersen Clinic Center for Cancer and Blood Disorders, 1900 South Ave, EB2-001,, La Crosse, Wisconsin, United States
The Medical City, 1609 MATI Building, The Medical City, Ortigas Avenue,, Pasig City, Manila, 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
Saint Lukes Medical Center, Rm 222 MAB Saint Lukes Medical Center, E. Rodriguez, Quezon City, , Philippines
Darent Valley Hospital Dept of Haematology, Acorn House, Darenth Wood Road, Dartford, Kent, United Kingdom
St Bartholomew's Hospital Haematology Department, 1st Floor, Pathology, Barbican, London, United Kingdom
Christie Hospital - Department Haematology, 550 Wilmslow Road, Withington, Manchester, Greater Manchester, United Kingdom
Hillingdon Hospital Dept of Haematology, Pield Health Road, Uxbridge, Middlesex, United Kingdom
Royal Marsden Hospital, Orchard House, Sutton, Surrey, United Kingdom
Royal Bournemouth Hospital, Dept. of Haematolgy, Castle Lane East,, Bournemouth, , United Kingdom
Royal Devon & Exeter Hospital Haematology Centre, Barrack Road, Exeter, , United Kingdom
Northwick Park Hospital Dept of Haematology, Watford Road, Harrow, , United Kingdom
St James Hospital, St James' Institute of Oncology, Department of Haematology, Level 03, Bexley Wing,, Leeds, , United Kingdom
UCL Cancer Institute, Paul O'Gorman Building, University College London,72 Huntley Street, London, , United Kingdom
Manchester Royal Infirmary Dept of Haematology, Oxford Road, Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust, Centre for Clinical Haemotology, Nottingham, , United Kingdom
Royal Cornwall Hospital Haematology Clinic, Truro, , United Kingdom
Contact Details
Name: Michael Kurman, MD
Affiliation: Kyowa Hakko Kirin Pharma, Inc.
Role: STUDY_DIRECTOR
Name: Loan Hoang-Sayag, MD
Affiliation: Quintiles, Inc.
Role: STUDY_CHAIR
Name: Noel Pingoy, MD
Affiliation: Gleneagles CRC
Role: STUDY_CHAIR
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