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Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.

Colorectal Cancer Clinical Trial

Official title:
A PHASE 1B, 12-WEEK, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS FOLLOWING REPEATED SUBCUTANEOUS ADMINISTRATIONS OF PF-06946860 IN PATIENTS WITH CANCER AND CACHEXIA

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

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