A Phase 2b/3, 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
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
• ECOG PS ≤1 with life expectancy of at least 4 months
Locations
United States
Illinois
Hope and Healing Cancer Services
NOT_YET_RECRUITING
Hinsdale
Hope and Healing Cancer Services New Lenox
NOT_YET_RECRUITING
New Lenox
Nevada
Renown Health Medical Oncology
RECRUITING
Reno
Renown Office of Clinical Research
RECRUITING
Reno
Renown Regional Medical Center
RECRUITING
Reno
Other Locations
Israel
Rabin Medical Center
NOT_YET_RECRUITING
Petah Tikva
Japan
National Hospital Organization Kyushu Cancer Center
NOT_YET_RECRUITING
Fukuoka
The University of Osaka Hospital
NOT_YET_RECRUITING
Suita
Puerto Rico
Pan American Center for Oncology Trials, LLC
RECRUITING
Rio Piedras
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-10-03
Estimated Completion Date: 2029-12-23
Participants
Target number of participants: 982
Treatments
Experimental: Double-Blind ponsegromab Treatment lower dose
ponsegromab 200 mg subcutaneous injection every 4 weeks
Experimental: Double-Blind ponsegromab Treatment higher dose
ponsegromab 400 mg subcutaneous injection every 4 weeks
Placebo_comparator: Double-Blind Placebo Treatment
Match placebo subcutaneous injection every 4 weeks
Related Therapeutic Areas
Sponsors
Leads: Pfizer