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Completed
NCT05546476
Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15
Conditions: Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Loss of Appetite, Fatigue, Cachexia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 187
Sponsor: Pfizer
Location: CARTI Conway Conway Arkansas
Summary
Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.
Eligibility Criteria
Key Inclusion Criteria:
* Documented active diagnosis of non-small cell lung, pancreatic, colorectal cancer
* Cachexia defined by Fearon criteria of weight loss
* Serum GDF-15 concentrations
* Signed informed consent
* ECOG PS ≤3 with life expectancy of at least 4 months to be able to complete Part A.
Key Exclusion Criteria:
* Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
* Current active reversible causes of decreased food intake.
* Cachexia caused by other reasons.
* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody.
* inadequate liver function
* renal disease requiring dialysis
Source: ClinicalTrials.gov (NCT05546476). StuddyBuddy aggregates publicly available trial information.
