NCT04299048

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cachexia
• Non-Small-Cell Lung Cancer
• Pancreatic Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	PF-06946860	subcutaneous injection

Timeline

• Start date: 2020-11-17
• Primary completion: 2022-03-30
• Completion: 2022-03-30
• First posted: 2020-03-06
• Last updated: 2023-12-14
• Results posted: 2023-12-14

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study