Spots Global Cancer Trial Database for Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
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Trial Identification
Brief Title: 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
Study ID: NCT04803305
Study Description
Brief 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.
Detailed 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CARTI Cancer Center, Little Rock, Arkansas, United States
Tower Hematology Oncology Medical Group (THO), Beverly Hills, California, United States
Ventura County Hematology- Oncology Specialists, Camarillo, California, United States
Cedars- Sinai Medical Center, Los Angeles, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
Ventura County Hematology Oncology Specialists, Oxnard, California, United States
Providence Medical Foundation, Santa Rosa, California, United States
Ventura County Hematology-Oncology Specialists, Ventura, California, United States
Lutheran Medical Center, Wheat Ridge, Colorado, United States
Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne, Indiana, United States
Bozeman Health Cancer Center, Bozeman, Montana, United States
Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research, Bozeman, Montana, United States
Bozeman Health Deaconess Hospital, Bozeman, Montana, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
US Oncology Investigational Product Center (IPC), Irving, Texas, United States
Texas Oncology - Longview Cancer Center, Longview, Texas, United States
Texas Oncology-Paris, Paris, Texas, United States
Texas Oncology- Tyler, Tyler, Texas, United States
Cancer Center IDS Pharmacy, Charlottesville, Virginia, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
UVA Health System; Attention: GI Team, Charlottesville, Virginia, United States
University of Virginia Health System, Charlottesville, Virginia, United States
MultiCare Regional Cancer Center - Auburn, Auburn, Washington, United States
MultiCare Regional Cancer Center - Gig Harbor Medical Park, Gig Harbor, Washington, United States
Moses Lake Clinic, Moses Lake, Washington, United States
MultiCare Regional Cancer Center - Puyallup, Puyallup, Washington, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers), Spokane Valley, Washington, United States
MultiCare Institute for Research & Innovation, Tacoma, Washington, United States
MultiCare Regional Cancer Center - Tacoma, Tacoma, Washington, United States
Wenatchee Valley Hospital, Wenatchee, Washington, United States
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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