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NCT Number: NCT01063907

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

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).

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Cardiovascular Diseases Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphoid Lung Diseases Lung Diseases, Obstructive Lymphatic Diseases Lymphoproliferative Disorders Monoclonal Gammopathy of Undetermined Significance Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Organizing Pneumonia Paraproteinemias Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Medical City, 1609 MATI Building, The Medical City, Ortigas Avenue,, Pasig, Manila, Philippines

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KW-2478

Drug

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

Other names: HSP90 Inhibitor

bortezomib

Drug

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

Other names: Velcade

Primary outcomes

  1. To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).

    Time frame: 21 day cycle, up to 52 weeks

    The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses.

    The ORR, was defined as the best response over a specified number of cycles (calculated and summarized).

    Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized).

Secondary outcomes

  1. Phase 1: PK Absorption Tmax hr Day 11

    Time frame: PK collected Day 11 of 21-day cycle

    Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.

  2. Phase 1: PK Exposure Cmax ng/mL Day 11

    Time frame: PK collected Day 11 of 21-day cycle

    Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.

  3. Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11

    Time frame: PK collected Day 11 of 21-day cycle

    Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.

  4. Phase 1: PK Elimination t½ hr Day 11

    Time frame: PK collected Day 11 of 21-day cycle

    Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Collaborators

  • Kyowa Hakko Kirin Pharma, Inc.

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 5, 2010
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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