A Phase 2, Multicenter, Randomized, Double blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in Participants with Colorectal Cancer who have Cancer Cachexia
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Colorectal Cancer with Cancer Cachexia
Спонсор: Ngm Biopharmaceuticals Inc.
Налично на:
БГ
Обобщение
Trial status: Authorised
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.
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
Описание
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.
Кой може да участва
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 54 participants