A phase 2, open-label study of S-6810 in patients with mycosis fungoides or Sezary syndrome
Phase 2
- Conditions
- Mycosis fungoides or Sezary syndrome
- Registration Number
- JPRN-jRCT2080221783
- Lead Sponsor
- SHIONOGI & CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Main inclusion criteria
1. Patients with mycosis fungoides or Sezary syndrome confirmed by cutaneous symptom, histopathological diagnosis or hematological evidence
2. Patients whose TNMB staging criterion is T1-4N0-2M0B0-2 and meet any of the following:
a) untreated mycosis fungoides/Sezary syndrome
b) at least 4 weeks after treatment for mycosis fungoides/Sezary syndrome
c) the effect of topical steroid, topical vitamin D3 derivatives, or ultraviolet therapy for mycosis fungoides/Sezary syndrome is stable or progressive within 4 weeks
3. Patients whose ECOG performance status is grade 0-2
Exclusion Criteria
Main exclusion criteria:
Patients whose visceral metastasis was found by imaging evaluation within 4 weeks prior to enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy (response rate)
- Secondary Outcome Measures
Name Time Method Safety