Trial record 1 of 1 for:    0761-010
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Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )
ClinicalTrials.gov Identifier:
NCT01728805
First received: October 25, 2012
Last updated: February 16, 2016
Last verified: February 2016
  Purpose
The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.

Condition Intervention Phase
Cutaneous T-Cell Lymphoma
Biological: KW-0761
Drug: Vorinostat
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Kyowa Kirin Pharmaceutical Development, Inc.:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pruritis Evaluation [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  • Overall Response Rate [ Time Frame: at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13), and every 16 weeks (cycle 17, 21, etc.) in Year 2 and beyond until progression up to 36 months ] [ Designated as safety issue: No ]
  • Quality of Life Assessments [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

Enrollment: 373
Study Start Date: November 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KW-0761
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)
Biological: KW-0761
1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Other Names:
  • mogamulizumab
  • POTELIGEO®
Active Comparator: Vorinostat
vorinostat 400 mg once daily
Drug: Vorinostat
Other Names:
  • 400 mg orally daily
  • ZOLINZA®

Detailed Description:
Phase 3 randomized study to compare the progression free survival of subjects with relapsed/refractory CTCL who receive KW-0761 versus those who receive vorinostat. Subjects who progress on vorinostat will be allowed to cross over to KW-0761 upon progression.
  Eligibility

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

Inclusion Criteria:

  • Males and female subjects ≥ 18 years of age at the time of enrollment, except in Japan where subjects must be ≥ 20 years of age at the time of enrollment
  • Histologically confirmed diagnosis of mycosis fungoides (MF) or Sezary Syndrome (SS)
  • Stage IB, II-A, II-B, III and IV
  • Subjects who have failed at least one prior course of systemic therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at study entry
  • Resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0)
  • Adequate hematological, renal and hepatic function
  • Subjects previously treated with anti-CD4 antibody or alemtuzumab are eligible provided their CD4+ cell counts are ≥ 200/mm3
  • Subjects with mycosis fungoides (MF) and a known history of non-complicated staphylococcus infection/colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics
  • Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of receiving study medication
  • WOCBP and male subjects as well as their female partners of childbearing potential must agree to use effective contraception throughout the study

Exclusion Criteria:

  • Prior treatment with KW-0761 or vorinostat.
  • Large cell transformation. However, subjects with a history of LCT but without current aggressive disease and no current evidence of LCT on pathology in skin and lymph nodes would be eligible.
  • Diagnosed with a malignancy in the past two years. However, subjects with non-melanoma skin cancers, melanoma in situ, localized cancer of the prostate with current PSA of <0.1 ng/mL, treated thyroid cancer or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast within the past two years may enroll as long as there is no current evidence of disease.
  • Clinical evidence of central nervous system (CNS) metastasis.
  • Psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements.
  • Significant uncontrolled intercurrent illness
  • Known or tests positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B or hepatitis C.
  • Active herpes simplex or herpes zoster. Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, and have no active signs of active infection, and whose last active infection was more than 6 months ago, may enter the study, and should continue to take the prescribed medication for the duration of the study.
  • Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
  • Known active autoimmune disease will be excluded. (For example, Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).
  • Is pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating.
  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: NCT01728805

  Hide Study Locations
Locations
United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Banner MD Anderson
Gilbert, Arizona, United States, 85234
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
UCLA Medical Center
Los Angeles, California, United States, 90095
Stanford Medical Center
Stanford, California, United States, 94305
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
The Winship Cancer Institute (Emory University)
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
United States, Louisiana
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Medical Center, Department of Medicine, Section of Hem/Onc
Boston, Massachusetts, United States, 02118
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Universal Dermatology, PLLC
Fairport, New York, United States, 14450
Columbia Presbyterian
New York, New York, United States, 10037
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
University of Rochester School of Medicine
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15208
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
M.D.Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53266
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Peter McCallum Cancer Center
East Melbourne, Victoria, Australia, 3002
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
France
CHU de Nantes
Nantes, France, 44093
Hôpital Saint Louis
Paris, France, 75010
CHU Bordeaux - Hopital Haut-Leveque
Pessac, France, 33604
Centre Hospitalier Lyon Sud
Pierre-Benite Cedex, France, 69495
Germany
University Medical Centre Mannheim
Mannheim, Germany, D-68167
University Hospital Muenster
Muenster, Germany, 48149
Italy
Institute of Hematology and Oncology Lorenzo e Ariosto Seràgnoli, University of Bologna
Bologna, Italy, 40138
Universita degli Studi di Torino
Turin, Italy, 10124
Japan
Nagoya City University Hospital
Nagoya-shi, Aichi, Japan, 467-8602
Fukushima Medical University Hospital
Fukushima-shi, Fukushima, Japan, 960-1295
Gunma University Hospital
Maebashi-shi, Gunma, Japan, 371-8511
Hiroshima University Hospital
Hiroshima-shi, Hiroshima, Japan, 734-8551
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan, 078-8510
Imamura Bun-in Hospital
Kagoshima-shi, Kagoshima, Japan, 890-0064
Yokohama City University Hospital
Yokohama-shi, Kanagawa, Japan, 236-0004
Kochi Medical School Hospital
Nankoku-shi, Kochi, Japan, 783-8505
Mie University Hospital
Tsu-shi, Mie, Japan, 514-8507
Tohoku University Hospital
Sendai-shi, Miyagi, Japan, 980-8574
Shinshu University Hospital
Matsumoto-shi, Nagano, Japan, 390-8621
Okayama University Hospital
Okayama-shi, Okayama, Japan, 700-8558
Kansai Medical University Hirakata Hospital
Hirakata-shi, Osaka, Japan, 571-1191
Osaka University Hospital
Suita-shi, Osaka, Japan, 565-0871
Hamamatsu University Hospital
Hamamatsu-shi, Shizuoka, Japan, 431-3192
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan, 113-8655
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Tokyo Metropolitan Tama Medical Center
Fuchu-shi, Tokyo, Japan, 183-8524
Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan, 135-8550
Netherlands
Leiden University Medical Center - Leids Universitair Medisch Centrum (LUMC)
Leiden, Netherlands, 2300RC
Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
United Kingdom
The Christie Hospital Foundation NHS Trust
Manchester, Greater Manchester, United Kingdom, M20 4BX
University Hospital Birmingham
Birmingham, United Kingdom, B15 2TH
Guys & St. Thomas NHS Trust
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
Investigators
Study Director: Dmitri O. Grebennik, MD Kyowa Hakko Kirin Pharma, Inc.
  More Information

Responsible Party: Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01728805     History of Changes
Other Study ID Numbers: 0761-010 
Study First Received: October 25, 2012
Last Updated: February 16, 2016
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: The Italian Medicines Agency
Denmark: Danish Health and Medicines Authority
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Paul-Ehrlich-Institut
Switzerland: Swissmedic
Japan: Pharmaceuticals and Medical Devices Agency
Australia: Human Research Ethics Committee

Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc.:
Cutaneous T-Cell Lymphoma (CTCL)
myocis fungoides (MF)
Sezary Syndrome (SS)

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Vorinostat
Antineoplastic Agents
Enzyme Inhibitors
Histone Deacetylase Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016