Breast Cancer Clinical Trial
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
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.
Full Description
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.
Eligibility Criteria
Key Inclusion Criteria:
Documented diagnosis of non-small cell lung, pancreatic, colorectal, prostate, breast or ovarian cancer which, in the treating oncologist's assessment, is considered advanced.
Anorexia as defined by a score of ≤5 in the Cancer-Related Cachexia Symptom Assessment Appetite 7-day recall scale
Meets any of the following criteria at Randomization:
Not currently receiving antineoplastic therapy
On standard of care systemic antineoplastic therapy or treatment without curative intent
Signed informed consent.
Key Exclusion Criteria:
Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
Current active reversible causes of decreased food intake.
Current, severe gastrointestinal disease
Participants with known symptomatic brain metastases requiring steroids.
Active uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, HIV or participants with known AIDS-related illness
inadequate renal or liver function.
Women who are pregnant or breast-feeding
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There are 26 Locations for this study
Little Rock Arkansas, 72205, United States
Beverly Hills California, 90211, United States
Camarillo California, 93010, United States
Los Angeles California, 90048, United States
Los Angeles California, 90048, United States
Los Angeles California, 90048, United States
Oxnard California, 93030, United States
Santa Rosa California, 95403, United States
Ventura California, 93003, United States
Wheat Ridge Colorado, 80033, United States
Fort Wayne Indiana, 46804, United States
Bozeman Montana, 59715, United States
Bozeman Montana, 59715, United States
Bozeman Montana, 59715, United States
Dallas Texas, 75230, United States
Houston Texas, 77030, United States
Irving Texas, 75063, United States
Longview Texas, 75601, United States
Paris Texas, 75460, United States
Tyler Texas, 75702, United States
Charlottesville Virginia, 22903, United States
Charlottesville Virginia, 22903, United States
Charlottesville Virginia, 22903, United States
Charlottesville Virginia, 22908, United States
Auburn Washington, 98001, United States
Gig Harbor Washington, 98335, United States
Moses Lake Washington, 98837, United States
Puyallup Washington, 98372, United States
Spokane Valley Washington, 99216, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98405, United States
Wenatchee Washington, 98801, United States
Ottawa Ontario, K1H 8, Canada
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