Trials / Completed
CompletedNCT01728805
Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 372 (actual)
- Sponsor
- Kyowa Kirin, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | KW-0761 | 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression |
| DRUG | Vorinostat |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2017-03-01
- Completion
- 2021-02-17
- First posted
- 2012-11-20
- Last updated
- 2024-04-25
- Results posted
- 2019-04-11
Locations
73 sites across 11 countries: United States, Australia, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01728805. Inclusion in this directory is not an endorsement.