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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

NCT06989437

RecruitingPhase 2, Phase 3

Sponsor: Pfizer

Conditions: Cachexia, Metastatic Pancreatic Ductal Adenocarcinoma

Interventions: ponsegromab, placebo

Countries: United States, Australia, Belgium, Brazil, Bulgaria, Canada, China, France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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
* 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%
* 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

Locations (214)

Birmingham, Alabama, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Bryant, Arkansas, United States
Conway, Arkansas, United States
Little Rock, Arkansas, United States
North Little Rock, Arkansas, United States
Pine Bluff, Arkansas, United States
Encinitas, California, United States
Irvine, California, United States
Irvine, California, United States
La Jolla, California, United States
La Jolla, California, United States
La Jolla, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Orange, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
Santa Monica, California, United States
Santa Rosa, California, United States
Vista, California, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Athens, Georgia, United States
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