Status:
RECRUITING
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
Lead Sponsor:
Pfizer
Conditions:
Cachexia
Metastatic Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 c...
Detailed Description
A Phase 2b/3, randomized, double-blind, multicenter, multinational study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plu...
Eligibility Criteria
Inclusion
- Key inclusion Criteria:
- 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
- Key Exclusion Criteria:
- Current active reversible causes of decreased food intake
- Cachexia caused by other reasons
- History of heart failure
- Left ventricular ejection fraction \<50%
- Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
- History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients
- Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases
- Inadequate liver function
- Renal disease requiring dialysis or eGFR \<30 mL/min/1.73m2
Exclusion
Key Trial Info
Start Date :
October 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 23 2029
Estimated Enrollment :
982 Patients enrolled
Trial Details
Trial ID
NCT06989437
Start Date
October 3 2025
End Date
December 23 2029
Last Update
December 17 2025
Active Locations (33)
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1
Invision, LLC
Honolulu, Hawaii, United States, 96813
2
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
3
Cardiology Associates, Inc
‘Aiea, Hawaii, United States, 96701
4
Hope and Healing Cancer Services
Hinsdale, Illinois, United States, 60521