Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GD… (NCT05546476) | Clinical Trial Compass
CompletedPhase 2
Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15
United States187 participantsStarted 2022-11-21
Plain-language summary
Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Part A: Change From Baseline in Body Weight at Week 12