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

Last updated: April 5, 2023
Sponsor: Pfizer
Overall Status: Completed

Phase

1

Condition

Anorexia

Colon Cancer; Rectal Cancer

Vaginal Cancer

Treatment

PF-06946860

Placebo for PF-06946860

Clinical Study ID

NCT04803305
C3651010
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Documented diagnosis of non-small cell lung, pancreatic, colorectal, prostate, breastor ovarian cancer which, in the treating oncologist's assessment, is consideredadvanced.
  • Anorexia as defined by a score of ≤5 in the Cancer-Related Cachexia Symptom AssessmentAppetite 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 curativeintent
  • Signed informed consent.

Exclusion

Key Exclusion Criteria:

  • Receiving tube feedings or parenteral nutrition at the time of Screening orRandomization.
  • 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 orparticipants with known AIDS-related illness
  • inadequate renal or liver function.
  • Women who are pregnant or breast-feeding

Study Design

Total Participants: 18
Treatment Group(s): 2
Primary Treatment: PF-06946860
Phase: 1
Study Start date:
May 11, 2021
Estimated Completion Date:
August 09, 2022

Study 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.

Connect with a study center

  • Brampton Civic Hospital (William Osler Health System)

    Brampton, Ontario L6R 3J7
    Canada

    Site Not Available

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • CISSSBSL

    Rimouski, Quebec G5L 5T1
    Canada

    Site Not Available

  • Centre Integre Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec

    Trois-Rivieres, Quebec G8Z 3R9
    Canada

    Site Not Available

  • CARTI Cancer Center

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Tower Hematology Oncology Medical Group (THO)

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Providence Saint Joseph Medical Center

    Burbank, California 91505
    United States

    Site Not Available

  • Ventura County Hematology- Oncology Specialists

    Camarillo, California 93010
    United States

    Site Not Available

  • Pacific Shores Medical Group

    Huntington Beach, California 92648
    United States

    Site Not Available

  • Pacific Shores Medical Group

    Irvine, California 92618
    United States

    Site Not Available

  • Pacific Shores Medical Group

    Long Beach, California 90808
    United States

    Site Not Available

  • Cedars- Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California 90048
    United States

    Site Not Available

  • Pacific Shores Medical Group

    Newport Beach, California 92663
    United States

    Site Not Available

  • Ventura County Hematology Oncology Specialists

    Oxnard, California 93030
    United States

    Site Not Available

  • Providence Medical Foundation

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Pacific Shores Medical Group

    Torrance, California 90505
    United States

    Site Not Available

  • Ventura County Hematology-Oncology Specialists

    Ventura, California 93003
    United States

    Site Not Available

  • Lutheran Medical Center

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Danbury Hospital

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Norwalk Hospital

    Norwalk, Connecticut 06856
    United States

    Site Not Available

  • Rush University Medical Center Professional Office Building Infusion Pharmacy

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology, Inc.

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • American Oncology Partners of Maryland, PA

    Germantown, Maryland 20874
    United States

    Site Not Available

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • Siteman Cancer Center - North County

    Florissant, Missouri 63031
    United States

    Site Not Available

  • Barnes-Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Siteman Cancer Center - St Peters

    Saint Peters, Missouri 63376
    United States

    Site Not Available

  • Bozeman Health Cancer Center

    Bozeman, Montana 59715
    United States

    Site Not Available

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana 59715
    United States

    Site Not Available

  • Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research

    Bozeman, Montana 59715
    United States

    Site Not Available

  • New York Oncology Hematology PC

    Albany, New York 12206
    United States

    Site Not Available

  • New York Oncology Hematology PC

    Clifton Park, New York 12065
    United States

    Site Not Available

  • The Christ Hospital Medical Specialists II Hematology Oncology

    Cincinnati, Ohio 45249
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • OHSU Center for Health and Healing

    Portland, Oregon 97239
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Texas Oncology - Austin Midtown

    Austin, Texas 78705
    United States

    Site Not Available

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • US Oncology Investigational Product Center (IPC)

    Irving, Texas 75063
    United States

    Site Not Available

  • Texas Oncology - Longview Cancer Center

    Longview, Texas 75601
    United States

    Site Not Available

  • Texas Oncology-New Braunfels

    New Braunfels, Texas 78130
    United States

    Site Not Available

  • Texas Oncology-Paris

    Paris, Texas 75460
    United States

    Site Not Available

  • Texas Oncology-San Antonio Downtown

    San Antonio, Texas 78212
    United States

    Site Not Available

  • Texas Oncology- Tyler

    Tyler, Texas 75702
    United States

    Site Not Available

  • Cancer Center IDS Pharmacy

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • UVA Health System; Attention: GI Team

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University of Virginia Cancer Center

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • MultiCare Regional Cancer Center - Auburn

    Auburn, Washington 98001
    United States

    Site Not Available

  • MultiCare Regional Cancer Center - Gig Harbor Medical Park

    Gig Harbor, Washington 98335
    United States

    Site Not Available

  • Moses Lake Clinic

    Moses Lake, Washington 98837
    United States

    Site Not Available

  • MultiCare Regional Cancer Center - Puyallup

    Puyallup, Washington 98372
    United States

    Site Not Available

  • VA Puget Sound HCS

    Seattle, Washington 98108
    United States

    Site Not Available

  • Medical Oncology Associates, PS (dba Summit Cancer Centers)

    Spokane, Washington 99208
    United States

    Site Not Available

  • Medical Oncology Associates, PS (dba Summit Cancer Centers)

    Spokane Valley, Washington 99216
    United States

    Site Not Available

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington 98405
    United States

    Site Not Available

  • MultiCare Regional Cancer Center - Tacoma

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Wenatchee Valley Hospital

    Wenatchee, Washington 98801
    United States

    Site Not Available

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