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

Sponsored by Pfizer

About this trial

Last updated 2 years ago

Study ID

C3651003

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 months ago

What is this trial about?

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

What are the Participation Requirements?

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

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Active, not recruiting