A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

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

Treatment groups

982 Participants
are divided into 3 treatment groups

Sponsors and collaborators