Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia

Official Title

A 6-week, randomized, double-blind, sponsor-open study to assess the effect of repeated subcutaneous administration of pf-06946860 on appetite in participants with advanced cancer and anorexia, followed by an 18-week open-label treatment period

Summary:

Study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated subcutaneous (SC-injected under the skin) doses.

Trial Description

Primary Outcome:

• effect of PF 06946860 compared to placebo on appetite

Secondary Outcome:

• effect of PF 06946860 compared to placebo on appetite
• effect of PF 06946860 compared to placebo on fatigue
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
• Incidence of laboratory abnormalities [Safety and Tolerability]

A 6 week double blind study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated doses injected under the skin (subcutaneously).

During the initial 6-week treatment period (Part A), a total of 2 doses of study drug or placebo will be administered 3 weeks apart. Each dose contains two injections. Part B is an optional 18-week open-label treatment period where up to 7 doses of study drug may be administered. Part B does not include placebo.

Assessments include:

• Measure the impact of the study drug on appetite, fatigue, and pain questionnaires
  
• Body weight measurements
  
• Blood samples to evaluate safety and additional endpoints including the amount of the study drug in the blood and the effects of the study drug on levels of a specific cytokine.

View this trial on ClinicalTrials.gov