Cutaneous T-cell lymphoma (CTCL) MedDRA version: 8.1 Level: LLT Classification code 10011677 Term: Cutaneous T-cell lymphoma
Conditions
Interventions
Product Name: Vorinostat
Product Code: MK-0683
Pharmaceutical Form: Capsule*
INN or Proposed INN: Vorinostat
CAS Number: 149647-78-9
Current Sponsor code: MK-0683
Other descriptive name: N-hydroxy-N’-
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has cutaneous manifestations of CTCL, with progressive, persistent, or recurrent disease on or following two systemic therapies. 2. Patient’s age is = 18 years. 3. Female patient is either post menopausal, free from menses for > 2 years, surgically sterilized or willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from heterosexual activity throughout the study, starting with visit 1. 4. For males, patient agrees to use an adequate method of contraception for the duration of the study and for 30 days after the last dose of study medication. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient is currently under treatment with any potential histone deacetylase (HDAC) inhibitor (e.g., valproic acid). 2. Patient is currently receiving other systemic treatment for CTCL other than corticosteroids at a dose of no more than the equivalent of 20 mg of prednisone daily. 3. Patient is pregnant or lactating. 4. Patient has known allergy to any component of the study drug. 5. Patient is eligible for any other study of vorinostat in CTCL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide drug on a compassionate use basis for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent, or recurrent disease on or following two systemic therapies and who would not otherwise have access to vorinostat. ;Secondary Objective: To assess the safety and tolerability of treatment with vorinostat in patients with CTCL in a compassionate use setting. To assess the efficacy of vorinostat in patients with CTCL in a compassionate use setting.;Primary end point(s): The primary efficacy endpoint is the response rate to oral vorinostat in patients with advanced CTCL as measured by the physician assessment. | — |
Countries
Denmark, Finland, Germany, Ireland, Italy, Netherlands, Slovenia
Outcome results
None listed