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.

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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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT04803305

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 26 Locations for this study

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CARTI Cancer Center
Little Rock Arkansas, 72205, United States
Tower Hematology Oncology Medical Group (THO)
Beverly Hills California, 90211, United States
Ventura County Hematology- Oncology Specialists
Camarillo California, 93010, United States
Cedars- Sinai Medical Center
Los Angeles California, 90048, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles California, 90048, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
Ventura County Hematology Oncology Specialists
Oxnard California, 93030, United States
Providence Medical Foundation
Santa Rosa California, 95403, United States
Ventura County Hematology-Oncology Specialists
Ventura California, 93003, United States
Lutheran Medical Center
Wheat Ridge Colorado, 80033, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne Indiana, 46804, United States
Bozeman Health Cancer Center
Bozeman Montana, 59715, United States
Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research
Bozeman Montana, 59715, United States
Bozeman Health Deaconess Hospital
Bozeman Montana, 59715, United States
Mary Crowley Cancer Research
Dallas Texas, 75230, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
US Oncology Investigational Product Center (IPC)
Irving Texas, 75063, United States
Texas Oncology - Longview Cancer Center
Longview Texas, 75601, United States
Texas Oncology-Paris
Paris Texas, 75460, United States
Texas Oncology- Tyler
Tyler Texas, 75702, United States
Cancer Center IDS Pharmacy
Charlottesville Virginia, 22903, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22903, United States
UVA Health System; Attention: GI Team
Charlottesville Virginia, 22903, United States
University of Virginia Health System
Charlottesville Virginia, 22908, United States
MultiCare Regional Cancer Center - Auburn
Auburn Washington, 98001, United States
MultiCare Regional Cancer Center - Gig Harbor Medical Park
Gig Harbor Washington, 98335, United States
Moses Lake Clinic
Moses Lake Washington, 98837, United States
MultiCare Regional Cancer Center - Puyallup
Puyallup Washington, 98372, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane Valley Washington, 99216, United States
MultiCare Institute for Research & Innovation
Tacoma Washington, 98405, United States
MultiCare Regional Cancer Center - Tacoma
Tacoma Washington, 98405, United States
Wenatchee Valley Hospital
Wenatchee Washington, 98801, United States
The Ottawa Hospital Cancer Centre
Ottawa Ontario, K1H 8, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT04803305

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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