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Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15
Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

NCT05546476

CompletedPhase 2

Sponsor: Pfizer

Conditions: Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Loss of Appetite, Fatigue

Interventions: ponsegromab, Placebo for ponsegromab

Countries: United States, Australia, Bulgaria, Canada, China, Hungary, Japan, Poland

Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (78)
  • Conway, Arkansas, United States
  • Little Rock, Arkansas, United States
  • North Little Rock, Arkansas, United States
  • Stuttgart, Arkansas, United States
  • Anaheim, California, United States
  • Beverly Hills, California, United States
  • Redlands, California, United States
  • Santa Rosa, California, United States
  • Lafayette, Indiana, United States
  • Baton Rouge, Louisiana, United States
  • Marrero, Louisiana, United States
  • Bozeman, Montana, United States
  • Portland, Oregon, United States
  • Portland, Oregon, United States
  • Portland, Oregon, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Seattle, Washington, United States
  • Wenatchee, Washington, United States
  • Darlinghurst, New South Wales, Australia
  • Orange, New South Wales, Australia
  • Melbourne, Victoria, Australia
  • St Albans, Victoria, Australia
  • Burgas, Bulgaria
  • Haskovo, Bulgaria
  • Rousse, Bulgaria
  • Shumen, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • + 48 more on CT.gov