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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

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllPfizer
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค1 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
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What it tests

  • ponsegromab
  • placebo
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Where

230 sites
The Kirklin Clinic of UAB Hospital
Birmingham, United States
The University of Alabama at Birmingham
Birmingham, United States
Mayo Clinic Hospital
Phoenix, United States
Central Arkansas Radiation Therapy Institute, dba CARTI
Bryant, United States
Central Arkansas Radiation Therapy Institute, dba CARTI
Conway, United States
CARTI Cancer Center
Little Rock, United States
Central Arkansas Radiation Therapy Institute, dba CARTI
North Little Rock, United States
Central Arkansas Radiation Therapy Institute, dba CARTI
Pine Bluff, United States

โ€ฆand 222 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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