About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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%
Trial design
Treatments tested in this trial
- ponsegromab
- placebo