Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Weight Loss

Pancreatic Neoplasms

Fatigue

Anorexia

Body Weight

Wasting Syndrome

Cachexia

Syndrome

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Signs and Symptoms, Digestive

Pancreatic Cancer

ponsegromab low dose subcutaneous injection every 4 weeks

Match placebo subcutaneous injection every 4 weeks

ponsegromab medium dose subcutaneous injection every 4 weeks

ponsegromab high dose subcutaneous injection every 4 weeks

Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment

ponsegromab

Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment

Placebo for ponsegromab

Pfizer CT.gov Call Center

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

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.

Assessments include:

* Body weight measurements
* Measure the impact of ponsegromab compared to placebo on physical activity.
* Measure the impact of ponsegromab compared to placebo on appetite, fatigue, nausea, vomiting and physical function questionnaires.
* Blood samples to evaluate safety and additional endpoints including the amount of study drug in the blood and the effects of the study drug on levels of GDF15
* Up to 3 additional blood samples (two samples during Part A and one sample during Part B, if relevant) in a subset of participants as part of a substudy for more comprehensive assessment of the amount of study drug in the blood and of the effects of the study drug on levels of GDF-15.

Double-blind for 12-week double-blind treatment period followed by an up to 1 year optional open-label treatment period

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

A PHASE 2, RANDOMIZED, 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 (PROACC -1)

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

evaluation of physical activity (Sedentary, light and moderate) and gait speed.

FACT-G score sums 27 items; ACS score sums 12 items; both use a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life.

Self-reported questionnaire that measures severity of symptoms related to cancer cachexia: appetite, nausea, vomiting, and fatigue.

Spots Global Cancer Trial Database for placebo for ponsegromab