The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
- Transformed MF
- 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 µg/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.
Kyowa Hakko Kirin Pharma, Inc.
Karen Dwyer 609-580-7362 KW0761clinicalinfo@kyowa-kirin-pharma.com
Mary Llorente 609-580-7315 KW0761clinicalinfo@kyowa-kirin-pharma.com
University of Rochester School of Medicine
Rochester, New York, United States, 14642
Contact: Carolina Alexander 585-489-2883 email@example.com
Principal Investigator: Brian Poligone, MD, PhD