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.
The purpose of the Phase 2b portion of the study is to determine the ponsegromab Q4W dose for the Phase 3/OLE portions of the study.
The purpose of the Phase 3 portion of the study is to demonstrate the efficacy, safety and tolerability of ponsegromab compared to placebo in adults with cachexia and mPDAC. All participants will have completed 1 × 28-day cycle of nab-paclitaxel and gemcitabine or 2 × 14-day cycles of FOLFIRINOX, prior to initiation of study intervention treatment. The optional OLE will start once the Phase 3 portion has accrued the number of survival
events to assess overall survival.
The objectives of the main study are based on the effect of ponsegromab compared with placebo in participants with cachexia and mPDAC. In addition to study intervention, all participants will also be receiving first-line chemotherapy treatment.
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
- Robert Wood Johnson University Hospital, Somerset
- Rutgers University
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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