Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
Verified September 2014 by Kyowa Hakko Kirin Pharma, Inc.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
First received: October 25, 2012
Last updated: September 8, 2014
Last verified: September 2014
The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.
Cutaneous T-Cell Lymphoma
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2016 (Final data collection date for primary outcome measure)
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)
1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Active Comparator: Vorinostat
vorinostat 400 mg once daily
- 400 mg orally daily
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
- 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.
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
Kyowa Hakko Kirin Pharma, Inc.
||Dmitri O. Grebennik, MD
||Kyowa Hakko Kirin Pharma, Inc.
No publications provided
||Kyowa Hakko Kirin Pharma, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 25, 2012
||September 8, 2014
||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)
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:
ClinicalTrials.gov processed this record on October 23, 2014
Lymphoma, T-Cell, Cutaneous
Immune System Diseases
Neoplasms by Histologic Type
Histone Deacetylase Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs