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

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.

Study Overview

• Status: Completed
• Conditions: Anorexia; Breast Cancer; Fatigue; Colorectal Cancer; Pancreatic Cancer; Ovarian Cancer; Prostate Cancer; Cachexia; Non-small Cell Lung Cancer; Loss of Appetite
• Intervention / Treatment: Drug: PF-06946860; Drug: Placebo for PF-06946860

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Cancer Centre
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • CARTI Cancer Center
  • California
    • Beverly Hills, California, United States, 90211
      • Tower Hematology Oncology Medical Group (THO)
    • Camarillo, California, United States, 93010
      • Ventura County Hematology- Oncology Specialists
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
    • Los Angeles, California, United States, 90048
      • Cedars- Sinai Medical Center
    • Oxnard, California, United States, 93030
      • Ventura County Hematology Oncology Specialists
    • Santa Rosa, California, United States, 95403
      • Providence Medical Foundation
    • Ventura, California, United States, 93003
      • Ventura County Hematology-Oncology Specialists
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
      • Lutheran Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Medical Oncology and Hematology, Inc.
  • Montana
    • Bozeman, Montana, United States, 59715
      • Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research
    • Bozeman, Montana, United States, 59715
      • Bozeman Health Deaconess Hospital
    • Bozeman, Montana, United States, 59715
      • Bozeman Health Cancer Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Mary Crowley Cancer Research
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Product Center (IPC)
    • Longview, Texas, United States, 75601
      • Texas Oncology - Longview Cancer Center
    • Paris, Texas, United States, 75460
      • Texas Oncology-Paris
    • Tyler, Texas, United States, 75702
      • Texas Oncology- Tyler
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Cancer Center
    • Charlottesville, Virginia, United States, 22903
      • Cancer Center IDS Pharmacy
    • Charlottesville, Virginia, United States, 22903
      • UVA Health System; Attention: GI Team
  • Washington
    • Auburn, Washington, United States, 98001
      • MultiCare Regional Cancer Center - Auburn
    • Gig Harbor, Washington, United States, 98335
      • MultiCare Regional Cancer Center - Gig Harbor Medical Park
    • Moses Lake, Washington, United States, 98837
      • Moses Lake Clinic
    • Puyallup, Washington, United States, 98372
      • MultiCare Regional Cancer Center - Puyallup
    • Spokane Valley, Washington, United States, 99216
      • Medical Oncology Associates, PS (dba Summit Cancer Centers)
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research & Innovation
    • Tacoma, Washington, United States, 98405
      • MultiCare Regional Cancer Center - Tacoma
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment; subcutaneous injection	Drug: PF-06946860; subcutaneous injection
Placebo Comparator: Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment; subcutaneous injection	Drug: PF-06946860; subcutaneous injection; Drug: Placebo for PF-06946860; subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 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 OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score were summarized descriptively by treatment group and timepoint.	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	The Cancer-Related Cachexia Symptom Assessment-Fatigue was a self-reported questionnaire that measured the severity of fatigue. The measure consisted of 1 question that asked study participants to rate their fatigue over the past 7 days from 0-"no fatigue" to 10-"worst possible fatigue", where higher score indicated worse fatigue. In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Fatigue score were summarized descriptively by treatment group and timepoint.	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	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs are events between first dose of study drug and up to discharge from study that are absent before treatment or that worsen relative to pretreatment state. An SAE is any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.	Day 1 through Week 6 (for a period of 6 weeks)
Number of Participants With Laboratory Test Abnormalities in Part A	Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, erythrocytes mean corpuscular volume, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, basophils, eosinophils and monocytes), chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate and glucose) and urine (pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes [/high power field (HPF)], urine leukocytes [/HPF] and hyaline casts [/low power field (LPF)]).	Days 1, 22 and 43

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): April 14, 2022
• Study Completion (Actual): August 9, 2022

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue
• Additional Relevant MeSH Terms: Metabolic Diseases; Signs and Symptoms, Digestive; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Thinness; Anorexia; Fatigue; Wasting Syndrome; Cachexia
• Other Study ID Numbers: C3651010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No