Chronic graft versus host disease.
Conditions
Brief summary
Phase 1: AUC, Phase 2: Proportion of participants who achieve an overall response (partial response [PR] or complete response [CR]) by Week 25 or Cycle 7 Day 1 whichever is first
Detailed description
Phase 1: Number of participants with treatment- emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs), Phase 1: Cmax, Phase 1: AUC0-6h, Phase 1: ORR, Phase 1: DOR, Phase 1: response by organ, Phase 1: failure-free survival (FFS), Phase 1: overall survival (OS), Phase 1: time to response (TTR), Phase 2: Number of participants with treatment- emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs), Phase 2: Ctrough of belumosudil, Phase 2: DOR, Phase 2: response by organ, Phase 2: FFS, Phase 2: OS, Phase 2: time to response (TTR)
Interventions
Sponsors
Sanofi-Aventis Recherche & Developpement
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: AUC, Phase 2: Proportion of participants who achieve an overall response (partial response [PR] or complete response [CR]) by Week 25 or Cycle 7 Day 1 whichever is first | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1: Number of participants with treatment- emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs), Phase 1: Cmax, Phase 1: AUC0-6h, Phase 1: ORR, Phase 1: DOR, Phase 1: response by organ, Phase 1: failure-free survival (FFS), Phase 1: overall survival (OS), Phase 1: time to response (TTR), Phase 2: Number of participants with treatment- emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs), Phase 2: Ctrough of belumosudil, Phase 2: DOR, Phase 2: response by organ, Phase 2: FFS, Phase 2: OS, Phase 2: time to response (TTR) | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain
Outcome results
None listed