Open-Label, Multi-Center, Dose Escalation Phase 1/2 Study of Anti-CCR4 Monoclonal Antibody KW-0761 as Monotherapy in Subjects With Previously Treated Peripheral T-Cell Lymphoma
This Phase 1/2, multicenter, open-label, dose escalation clinical study will enroll up to 47
subjects with previously treated PTCL including CTCL. The study is comprised of a dose
escalation phase (Phase 1) and a preliminary assessment of efficacy (Phase 2).
In the dose escalation phase, the starting dose will be 0.1 mg/kg administered i.v. once
every week for four weeks, followed by a 2-week observation period in the first treatment
course. Succeeding dose levels will include 0.3 and 1 mg/kg. During the first course of
treatment if assessments performed at day 29 (end of week 4) indicate that a subject has
demonstrated an overall CR, the subject may continue on study for up to an additional four
infusions beyond CR on an every other week infusion schedule. Treatment will then be
discontinued in order to determine duration of response. If a subject experiences a PR or
SD, the subject may continue therapy after consultation between the investigator and the
medical monitor on an every other week infusion schedule until disease progression occurs or
other withdrawal criteria are met.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
6 weeks
Yes
Michael Kurman, MD
Study Director
Kyowa Hakko Kirin Pharma
United States: Food and Drug Administration
KW-0761-001
NCT00888927
May 2009
September 2012
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
Stanford Medical Center | Stanford, California 94303 |
Ronald Reagan UCLA Medical Center | Los Angeles, California 90095 |
M.D.Anderson Cancer Center | Houston, Texas 77030 |