A PHASE IIb/III, RANDOMIZED, DOUBLE-BLIND STUDY TO INVESTIGATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PONSEGROMAB (PF-06946860 COMPARED WITH PLACEBO BOTH WITH BACKGROUND FIRST-LINE CHEMOTHERAPY IN ADULT PARTICIPANTS WITH CACHEXIA AND METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA
Categories (click each to see list of all clinical trials associated with that category): GI (ONC), Pancreatic Cancer Center of Excellence - PCCE (ONC)
Current Status: Open
Phase: II/III (Cancer Control)
Principal Investigator: Klute, Kelsey
Contact Information:
Mahdi Hassan
mhassan@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06989437?term=nct06989437&rank=1#participation-criteria
Summary
Primary Objectives:
To evaluate the effect of ponsegromab compared with placebo on body weight.
To evaluate the effect of ponsegromab compared with placebo on the appetite-related symptoms as measured by
FAACT-5IASS.
Secondary Objectives:
To evaluate the effect of ponsegromab compared with placebo on physical activity as measured by wearable (Digital
Health Technology) DHT watch.
To evaluate the effect of ponsegromab compared with placebo on overall survival.
To evaluate the effect of ponsegromab compared with placebo on body weight.
To evaluate the effect of ponsegromab compared with placebo on physical activity as measured by wearable DHT watch.
To evaluate the effect of ponsegromab compared with placebo on the PFS.
To evaluate the effect of ponsegromab compared with placebo on the ORR.
To evaluate the effect of ponsegromab compared with placebo on the DCR.
To evaluate the effect of ponsegromab compared with placebo to estimate the DOR.
To evaluate the effect of ponsegromab compared with placebo on body composition.
To characterize the safety and tolerability of ponsegromab compared with placebo.
To evaluate the effect of ponsegromab compared with placebo on physical function and fatigue.
To evaluate the effect of ponsegromab compared with placebo on body weight, appetite, physical activity, physical function, and fatigue over time.
To evaluate the tolerability of ponsegromab compared with placebo.
To evaluate the effect of ponsegromab compared with placebo on chemotherapy administration.
To evaluate the impact of ponsegromab compared with placebo on tumor size.