Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.
Signed Informed Consent Document
Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma
Cachexia defined by Fearon criteria of weight loss
Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy
Current active reversible causes of decreased food intake
Cachexia caused by other reasons
Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification
Left ventricular ejection fraction <50%
Parallel
ponsegromab
DrugDouble-Blind ponsegromab Treatment
placebo
DrugDouble-Blind placebo Treatment
Percent change from baseline in body weight for ponsegromab compared to placebo
Change from baseline in Functional Assessment of Anorexia/Cachexia Therapy 5-item Anorexia Symptom Scale scores
Scale consists of five items, each rated 0-4. Total score ranges from 0 (minimum) to 20 (maximum). Higher scores are associated with a better outcome.
Change from baseline in non-sedentary physical activity time
measured by wearable Digital Health Technology watch
Overall survival
Outcome defined as the time from randomization to occurrence of all-cause death
Change from baseline in body weight (kg)
Change from baseline at Week 12 in physical activity as measured by total vector magnitude
measured by wearable Digital Health Technology watch