PROACC-1
Description A phase 2, randomised, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of ponsegromab in patients with cancer, cachexia, and elevated concentrations of GDF-15, followed by an optional open-label treatment period
Trial overview
Topic
Non-small cell lung cancer, Pancreatic cancer, colorectal cancer
Eligibility criteria
Key Inclusion Criteria:
- Documented 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
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 renal or liver function
Study details
A 12 week double blind study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.
During the initial 12-week treatment period (Part A), a total of 3 doses of ponsegromab or placebo will be administered 4 weeks apart subcutaneously. Each dose contains two injections. Part B is an optional open-label treatment period consisting of ponsegromab administered every 4 weeks subcutaneously for up to one year. Part B does not include placebo.
Further information
For more information regarding this clinical trial click here.
Location