Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
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
1 other identifier
interventional
18
2 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 nonsmall-cell-lung-cancer
Started May 2021
Shorter than P25 for phase_1 nonsmall-cell-lung-cancer
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2021
CompletedFirst Posted
Study publicly available on registry
March 17, 2021
CompletedStudy Start
First participant enrolled
May 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2022
CompletedResults Posted
Study results publicly available
January 12, 2024
CompletedJanuary 12, 2024
April 1, 2023
11 months
March 15, 2021
April 5, 2023
April 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A
The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-"no appetite" to 10-"very good appetite", where higher score indicated better appetite. In this Outcome Measure (OM), changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score at Week 4 were summarized descriptively by treatment group.
Baseline, Week 4
Secondary Outcomes (4)
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A
Baseline, Weeks 1, 2, 3, 5 and 6
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A
Baseline, Weeks 1, 2, 3, 4, 5 and 6
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A
Day 1 through Week 6 (for a period of 6 weeks)
Number of Participants With Laboratory Test Abnormalities in Part A
Days 1, 22 and 43
Study Arms (2)
Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment
EXPERIMENTALsubcutaneous injection
Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment
PLACEBO COMPARATORsubcutaneous injection
Interventions
subcutaneous injection
subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (33)
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 8L6, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-blind, sponsor open for 6-week double-blind treatment period followed by an optional 18-week open-label treatment period.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2021
First Posted
March 17, 2021
Study Start
May 11, 2021
Primary Completion
April 14, 2022
Study Completion
August 9, 2022
Last Updated
January 12, 2024
Results First Posted
January 12, 2024
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.