Cancer-associated Cachexia
Conditions
Brief summary
Change from baseline in body weight at 12 weeks; change from baseline in appetite at 12 weeks, measured on the 5-item anorexia subscale of the FAACT instrument, 12 weeks
Detailed description
1. Skeletal muscle mass/index by L3 CT/MRI scan; Functional endpoint (30-second chair stand test); Non-sedentary physical activity; Overall survival (OS); Tumor response; Responder analysis, 2. Incidence, type, and severity of treatment emergent Adverse Events (TEAEs), treatment-related AEs and serious AEs (SAEs), discontinuation due to TEAEs, 3. Patient-reported outcomes: Functional Assessment of Anorexia/Cachexia Therapy (FAACT); Patient Global Impression of Severity (PGI-S); Patient Global Impression of Change (PGI-C); EORTC-QLQ-C15 PAL, 4. Maximum plasma concentration (Cmax); Minimum plasma concentration (Cmin)
Interventions
DRUGPlacebo matching Visugromab (CTL-002)
Sponsors
CatalYm GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in body weight at 12 weeks; change from baseline in appetite at 12 weeks, measured on the 5-item anorexia subscale of the FAACT instrument, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Skeletal muscle mass/index by L3 CT/MRI scan; Functional endpoint (30-second chair stand test); Non-sedentary physical activity; Overall survival (OS); Tumor response; Responder analysis, 2. Incidence, type, and severity of treatment emergent Adverse Events (TEAEs), treatment-related AEs and serious AEs (SAEs), discontinuation due to TEAEs, 3. Patient-reported outcomes: Functional Assessment of Anorexia/Cachexia Therapy (FAACT); Patient Global Impression of Severity (PGI-S); Patient Global Impression of Change (PGI-C); EORTC-QLQ-C15 PAL, 4. Maximum plasma concentration (Cmax); Minimum plasma concentration (Cmin) | — |
Outcome results
None listed