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

Phase 1

Completed

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

• Registration Number: NCT04803305
• Lead Sponsor: Pfizer

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.

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 Timeline

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Study Start: 2021-05-11
• Primary Completion: 2022-04-14
• Study Completion: 2022-08-09
• Status Verified: 2023-04
• Results First Submitted: 2023-04-05
• Results First Submitted QC: 2023-04-05
• Last Update Submitted: 2023-04-05
• Results First Posted: 2024-01-12
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment	PF-06946860	subcutaneous injection
Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment	Placebo for PF-06946860	subcutaneous injection
Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment	PF-06946860	subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A	Baseline, Week 4	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.

Secondary Outcome Measures

Name	Time	Method
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)	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.
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	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.
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	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.
Number of Participants With Laboratory Test Abnormalities in Part A	Days 1, 22 and 43	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 \[/low power field (LPF)\]).

Trial Locations

Locations (33)

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Medical Oncology Associates, PS (dba Summit Cancer Centers); 🇺🇸 Spokane Valley, Washington, United States

MultiCare Regional Cancer Center - Tacoma; 🇺🇸 Tacoma, Washington, United States

Bozeman Health Cancer Center; 🇺🇸 Bozeman, Montana, United States

Bozeman Health Deaconess Hospital; 🇺🇸 Bozeman, Montana, United States

CARTI Cancer Center; 🇺🇸 Little Rock, Arkansas, United States

Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research; 🇺🇸 Bozeman, Montana, 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, Samuel Oschin Comprehensive Cancer Institute; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 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

Mary Crowley Cancer Research; 🇺🇸 Dallas, Texas, United States

Texas Oncology-Paris; 🇺🇸 Paris, Texas, United States

US Oncology Investigational Product Center (IPC); 🇺🇸 Irving, Texas, United States

Texas Oncology - Longview Cancer Center; 🇺🇸 Longview, Texas, United States

University of Virginia Cancer Center; 🇺🇸 Charlottesville, Virginia, United States

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

Texas Oncology- Tyler; 🇺🇸 Tyler, Texas, United States

MultiCare Regional Cancer Center - Gig Harbor Medical Park; 🇺🇸 Gig Harbor, Washington, United States

Cancer Center IDS Pharmacy; 🇺🇸 Charlottesville, Virginia, United States

UVA Health System; Attention: GI Team; 🇺🇸 Charlottesville, Virginia, United States

Moses Lake Clinic; 🇺🇸 Moses Lake, Washington, United States

MultiCare Regional Cancer Center - Puyallup; 🇺🇸 Puyallup, Washington, United States

MultiCare Regional Cancer Center - Auburn; 🇺🇸 Auburn, Washington, United States

Wenatchee Valley Hospital; 🇺🇸 Wenatchee, Washington, United States

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada

MultiCare Institute for Research & Innovation; 🇺🇸 Tacoma, Washington, United States