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Clinical Trial Summary

Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.


Clinical Trial Description

This 12-week open-label study will explore how PF-06946860 is tolerated, the effects of the study drug, the best dose for treatment and how participants with non-small cell lung, pancreatic or colorectal cancer and cachexia feel after receiving repeated subcutaneous dosing. During the 12-week treatment period, study drug will be administered subcutaneously every 3 weeks for a total of 5 doses. There is a 12-week follow-up period following the last dose of study drug. Additional assessments include: - body weight measurements - blood pressure and heart rate measurements - Lumbar Skeletal Muscle Index (LSMI) by CT scan - Blood samples: - to evaluate safety, - to measure the amount of the study drug in the blood, - to evaluate if the study drug causes an immune response, - to examine the effects of the study drug on levels of a specific cytokine, - and for exploratory samples for bio banking. - Measure the impact of the study drug on appetite, nausea, vomiting, fatigue, physical function, and health-related quality of life with questionnaires. - Measure the impact of study drug on physical activity using wearable digital sensors. - To evaluate the effect of study drug on ability to complete anti-tumor treatment and survival in participants with cancer and cachexia. - To evaluate tumor size. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04299048
Study type Interventional
Source Pfizer
Contact
Status Completed
Phase Phase 1
Start date November 17, 2020
Completion date March 30, 2022

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