Colorectal Cancer with Cancer Cachexia
Conditions
Brief summary
Change from baseline in body weight at Week 12, Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
Detailed description
Key: Change from baseline in body weight at Week 16, Change from baseline over time in: − FAACT sub-scale scores (FAACT-ACS, FAACT-5IASS) − PROMIS (fatigue 7a & physical function 8c) − PGI-S and PGI-C (appetite and fatigue) − PGI-S and PGI-C (physical activity and walking), Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug, Change in body weight over time, Serum concentration and PK parameters of NGM120., Incidence and titer of ADA and NAb over time.
Interventions
DRUGplacebo for NGM120
DRUGNGM120
Sponsors
Ngm Biopharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in body weight at Week 12, Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Key: Change from baseline in body weight at Week 16, Change from baseline over time in: − FAACT sub-scale scores (FAACT-ACS, FAACT-5IASS) − PROMIS (fatigue 7a & physical function 8c) − PGI-S and PGI-C (appetite and fatigue) − PGI-S and PGI-C (physical activity and walking), Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug, Change in body weight over time, Serum concentration and PK parameters of NGM120., Incidence and titer of ADA and NAb over time. | — |
Countries
Bulgaria, Czechia, Hungary, Poland, Slovakia
Outcome results
None listed