Compassionate Use of Vorinostat for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma (0683-042)
NCT00419367 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2022-09-22
Summary
In an effort to allow patients continued access to vorinostat outside of the base study, patients that are actively receiving study medication will discontinue from this study and receive vorinostat via another method supported by the SPONSOR (e.g. Named Patient Program (NPP)). For those institutions that do not allow receipt of an investigational therapy outside of a clinical trial, patients that are actively receiving study medication and
continue to meet eligibility will transition to an extension phase of the study and the base study will be closed.
The extension phase will begin as soon as the protocol amendment is implemented.
Conditions
- Lymphoma, T-Cell, Cutaneous
Interventions
- DRUG
-
Comparator: vorinostat
Each patient will receive open-label vorinostat 400 mg q.d. capsules. Treatment will continue until disease progression, intolerable toxicity, withdrawal of consent, or physician determines it is in best interest of patient to withdrawal.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Monitor · Merck Sharp & Dohme LLC
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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