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 currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Kyowa Hakko Kirin Pharma, Inc.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01728805
First received: October 25, 2012
Last updated: June 3, 2014
Last verified: June 2014
  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 Hakko Kirin Pharma, 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 (cycle 3,5,7,etc.)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 ]

Estimated Enrollment: 317
Study Start Date: November 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (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 progressed following 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 and their female partners of child bearing potential must agree to use effective contraception throughout the study

Exclusion Criteria:

  • Prior treatment with KW-0761 or vorinostat.
  • Large cell transformation.
  • Have had 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 with in 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

Contacts
Contact: Kyowa Hakko Kirin Pharma 1-609-919-1100 clinical.info@kyowa-kirin-pharma.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Rhonda Kaler    205-502-9967    rkaler@uabmc.edu   
Principal Investigator: Lauren Hughey, MD         
United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Baudelio Gutierrez    310-582-4046    bgutierrez@mednet.ucla.edu   
Principal Investigator: Herbert Eradat, MD, MS         
Stanford Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Illisha Rajasansi    650-725-1202    illisha@stanford.edu   
Principal Investigator: Youn H Kim, MD         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Thomas Prewitt    720-848-0208    thomas.prewitt@ucdenver.edu   
Principal Investigator: Theresa Pacheco, MD         
United States, Connecticut
Yale University School of Medicine - Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Stephanie Sellers    203-737-8358    stephanie.sellers@yale.edu   
Principal Investigator: Francine Foss, MD         
United States, Florida
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Elyce Turba    813-745-1706    elyce.turba@moffitt.org   
Principal Investigator: Lubomir Sokol, MD, PhD         
United States, Georgia
The Winship Cancer Institute (Emory University) Recruiting
Atlanta, Georgia, United States, 30322
Contact: Amanda Hutchinson-Rzepka    404-778-3935    ahutch7@emory.edu   
Principal Investigator: Mary Jo Lechowicz, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Angela Cisneros    312-695-1384    cisneros@northwestern.edu   
Principal Investigator: Timothy Kuzel, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Carmen Petrizzo    312-563-4001    carmen_m_petrizzo@rush.edu   
Principal Investigator: Michael Tharp, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Amelia Lengerich    317-274-8750    mlengeri@iu.edu   
Principal Investigator: Lawrence Mark, MD         
United States, Louisiana
Tulane University Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Edward Coleman    504-988-5135    ecoleman@tulane.edu   
Principal Investigator: Erin Boh, MD, PhD         
United States, Massachusetts
Boston Medical Center, Department of Medicine, Section of Hem/Onc Not yet recruiting
Boston, Massachusetts, United States, 02118
Contact: Juliana Merhaut    617-638-8280    juliana.merhaut@bmc.org   
Principal Investigator: Adam Lerner, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jessica Lantz    734-936-6936    jessicap@med.umich.edu   
Principal Investigator: Ryan Wilcox, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Mary Anderson    314-747-7399    manderso@dom.wustl.edu   
Principal Investigator: Kenneth Carson, MD         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Darcie Findley    603-650-4595    darcie.l.findley@hitchcock.org   
Principal Investigator: Frederick Lansigan, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Shant Keskinyan    646-449-1305    keskinyv@mskcc.org   
Principal Investigator: Alison Moskowitz, MD         
Columbia Presbyterian Recruiting
New York, New York, United States, 10037
Contact: Delcia Rivas    212-305-2696    dr2570@columbia.edu   
Principal Investigator: Adrienne Phillips, M.D., M.P.H.         
University of Rochester School of Medicine Recruiting
Rochester, New York, United States, 14642
Contact: Carolina Alexander    585-275-0796    carolina_alexander@urmc.rochester.edu   
Principal Investigator: Brian Poligone, MD, PhD         
United States, North Carolina
Wake Forest Baptist Medical Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Zanetta Lamar, M.D.         
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Joselin Tacastacas    216-844-5899    joselin.tacastacas@uhhospitals.org   
Principal Investigator: Neil Korman, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Michelle Messer    614-366-4470    Michelle.Messer@osumc.edu   
Principal Investigator: Pierluigi Porcu, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kathleen Kirchner    215-614-0808    Kathleen.kirchner@uphs.upenn.edu   
Principal Investigator: Ellen Kim, MD         
Thomas Jefferson University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Barbara Pro, MD         
University of Pittsburgh School of Medicine Recruiting
Pittsburgh, Pennsylvania, United States, 15208
Contact: Sue McCann    412-864-3681    mccannsa@upmc.edu   
Principal Investigator: Lisa Grandinetti, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Jessica Piggee    615-875-6120    jessica.l.piggee@vanderbilt.edu   
Principal Investigator: John Greer, MD         
United States, Texas
M.D.Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Carol Wilson, BSN,RN,OCN    713-563-4655    clwilson@mdanderson.org   
Principal Investigator: Madeleine Duvic, MD         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Karen Pena    801-213-4233    karen.pena@hci.utah.edu   
Principal Investigator: Ahmad Halwani         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98109
Contact: Kari Blankenship    206-288-1172    kblanken@seattlecca.org   
Principal Investigator: Andrei Shustov, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53266
Contact: Arielle Baim    414-805-8745    abaim@mcw.edu   
Principal Investigator: Sam Hwang, MD, PhD         
Australia, New South Wales
Westmead Hospital Not yet recruiting
Westmead, New South Wales, Australia, 2145
Principal Investigator: Jillian Wells         
Australia, South Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5000
Principal Investigator: Ian Lewis         
Flinders Medical Centre Not yet recruiting
Bedford Park, South Australia, Australia, 5042
Principal Investigator: Bryone Kuss         
Australia, Victoria
Peter McCallum Cancer Center Not yet recruiting
East Melbourne, Victoria, Australia, 3002
Principal Investigator: Amit Khot         
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Mette Thorup    +45 24244900    annthoru@rm.dk   
Principal Investigator: Lars Iversen         
France
CHU de Nantes Not yet recruiting
Nantes, France, 44093
Contact: Amir Khammari    +33 (0) 240083280    amir.khammari@chu-nantes.fr   
Principal Investigator: Brigitte Dreno         
Hôpital Saint Louis Recruiting
Paris, France, 75010
Contact: Halim Bataouche    +33 1 42 49 93 92    halim.bataouche@sls.aphp.fr   
Principal Investigator: Martine Bagot         
CHU Bordeaux - Hopital Haut-Leveque Recruiting
Pessac, France, 33604
Contact: Guillaume Villechenoux    +33 5 57 62 32 27    guillaume.villechenoux@chu-bordeaux.fr   
Principal Investigator: Marie Beylot-Barry         
Centre Hospitalier Lyon Sud Recruiting
Pierre-Benite Cedex, France, 69495
Contact: Myrtille Le Bouar    +33 4 78 86 15 96    myrtille.le-bouar@chu-lyon.fr   
Principal Investigator: Stephane Dalle         
Germany
University Medical Centre Mannheim Not yet recruiting
Mannheim, Germany, D-68167
Contact: Sylvia Pustal    +49 621-383-3919    s.pustal@dkfz.de   
Principal Investigator: Claus Klemke         
Wilhelms Universitaet Muenster Not yet recruiting
Muenster, Germany, 48149
Contact: Kirsten Buddendick    +49 251-835-6558    kirsten.buddendick@ukmuenster.de   
Principal Investigator: Athanasios Tsianakas         
Italy
Institute of Hematology and Oncology Lorenzo e Ariosto Seràgnoli, University of Bologna Recruiting
Bologna, Italy, 40138
Contact: Marta Tschon    +39 0516363227    marta.tschon2@unibo.it   
Principal Investigator: Pierluigi Zinzani         
Universita degli Studi di Torino Not yet recruiting
Turin, Italy, 10124
Contact: Renata Ponti    +39 011 6335858    trials.dermo.molinette@gmail.com   
Principal Investigator: Maria Theresa Fierro         
Japan
Nagoya City University Hospital Not yet recruiting
Nagoya-shi, Aichi, Japan, 467-8602
Principal Investigator: Shinsuke Iida         
Fukushima Medical University Hospital Recruiting
Fukushima-shi, Fukushima, Japan, 960-1295
Principal Investigator: Mikio Otsuka         
Gunma University Hospital Not yet recruiting
Maebashi-shi, Gunma, Japan, 371-8511
Principal Investigator: Osamu Ishikawa         
Hiroshima University Hospital Not yet recruiting
Hiroshima-shi, Hiroshima, Japan, 734-8551
Principal Investigator: Maiko Tanaka         
Imamura Bun-in Hospital Recruiting
Kagoshima-shi, Kagoshima, Japan, 890-0064
Principal Investigator: Kentaro Yonekura         
Yokohama City University Hospital Recruiting
Yokohama-shi, Kanagawa, Japan, 236-0004
Principal Investigator: Hidefumi Wada         
Mie University Hospital Not yet recruiting
Tsu-shi, Mie, Japan, 514-8507
Principal Investigator: Kenichi Isoda         
Tohoku University Hospital Not yet recruiting
Sendai-shi, Miyagi, Japan, 980-8574
Principal Investigator: Kenichi Ishizawa         
Shinshu University Hospital Not yet recruiting
Matsumoto-shi, Nagano, Japan, 390-8621
Principal Investigator: Hisashi Uhara         
Kansai Medical University Hirakata Hospital Not yet recruiting
Hirakata-shi, Osaka, Japan, 571-1191
Principal Investigator: Taiki Isei         
Osaka University Hospital Not yet recruiting
Suita-shi, Osaka, Japan, 565-0871
Principal Investigator: Mamori Tani         
Hamamatsu University Hospital Not yet recruiting
Hamamatsu-shi, Shizuoka, Japan, 431-3192
Principal Investigator: Yoshiki Tokura         
The University of Tokyo Hospital Not yet recruiting
Bunkyo-ku, Tokyo, Japan, 113-8655
Principal Investigator: Makoto Sugaya         
National Cancer Center Hospital Not yet recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Principal Investigator: Kensei Tobinai         
Tokyo Metropolitan Tama Medical Center Not yet recruiting
Fuchu-shi, Tokyo, Japan, 183-8524
Principal Investigator: Yukihiko Kato         
Japanese Foundation for Cancer Research Not yet recruiting
Koto-ku, Tokyo, Japan, 135-8550
Principal Investigator: Kiyohiko Hatake         
Netherlands
Leiden University Medical Center - Leids Universitair Medisch Centrum (LUMC) Recruiting
Leiden, Netherlands, 2300RC
Principal Investigator: Maarten Vermeer         
Spain
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Esther Vega    +34 917792261    evra_83@hotmail.com   
Principal Investigator: Pablo Ortiz-Romero         
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Contact: Eva Baeza Diez    +34 923291100    evadbaeza@yahoo.es   
Principal Investigator: Dolores Caballero         
Switzerland
University Hospital Zurich Not yet recruiting
Zurich, Switzerland, 8091
Contact: Katja Barmettler    +41 44 255 9485    katja.barmettler@usz.ch   
Principal Investigator: Reinhard Dummer         
United Kingdom
University Hospital Birmingham Recruiting
Birmingham, United Kingdom, B15 2TH
Contact: Hannah Worthington    +44 (0) 1212041602    hannah.worthington@uhb.nhs.uk   
Principal Investigator: Julia Scarisbrick         
Guys & St. Thomas NHS Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Nicholas Gomm    +44 (0)20 7188 7188 ext 51383    Nicholas.Gomm@gstt.nhs.uk   
Principal Investigator: Stephen Morris         
The Christie Hospital NHS Trust Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Cathy Spence    +44 (0) 1614468285    cathy.spence@christie.nhs.uk   
Principal Investigator: Richard Cowan         
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
Investigators
Study Director: Dmitri O. Grebennik, MD Kyowa Hakko Kirin Pharma, Inc.
  More Information

No publications provided

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: June 3, 2014
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 Hakko Kirin Pharma, Inc.:
Cutaneous T-Cell Lymphoma (CTCL)
myocis fungoides (MF)
Sezary Syndrome (SS)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Vorinostat
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014