Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
NCT ID: NCT04803305
Last Updated: 2024-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2021-05-11
2022-08-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment
subcutaneous injection
PF-06946860
subcutaneous injection
Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment
subcutaneous injection
PF-06946860
subcutaneous injection
Placebo for PF-06946860
subcutaneous injection
Interventions
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PF-06946860
subcutaneous injection
Placebo for PF-06946860
subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C3651010
Identifier Type: -
Identifier Source: org_study_id
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