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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04803305
• Other study ID #: C3651010
• Status: Completed
• Phase: Phase 1
• Start date: May 11, 2021
• Est. completion date: August 9, 2022

Study information

• Verified date: April 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 9, 2022
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Breast Cancer
• Cachexia
• Colorectal Cancer
• Fatigue
• Loss of Appetite
• Non-small Cell Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer

Intervention

Drug:
• PF-06946860
subcutaneous injection
• Placebo for PF-06946860
subcutaneous injection

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario
United States	MultiCare Regional Cancer Center - Auburn	Auburn	Washington
United States	Tower Hematology Oncology Medical Group (THO)	Beverly Hills	California
United States	Bozeman Health Cancer Center	Bozeman	Montana
United States	Bozeman Health Deaconess Hospital	Bozeman	Montana
United States	Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research	Bozeman	Montana
United States	Ventura County Hematology- Oncology Specialists	Camarillo	California
United States	Cancer Center IDS Pharmacy	Charlottesville	Virginia
United States	University of Virginia Cancer Center	Charlottesville	Virginia
United States	University of Virginia Health System	Charlottesville	Virginia
United States	UVA Health System; Attention: GI Team	Charlottesville	Virginia
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana
United States	MultiCare Regional Cancer Center - Gig Harbor Medical Park	Gig Harbor	Washington
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	US Oncology Investigational Product Center (IPC)	Irving	Texas
United States	CARTI Cancer Center	Little Rock	Arkansas
United States	Texas Oncology - Longview Cancer Center	Longview	Texas
United States	Cedars- Sinai Medical Center	Los Angeles	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute	Los Angeles	California
United States	Moses Lake Clinic	Moses Lake	Washington
United States	Ventura County Hematology Oncology Specialists	Oxnard	California
United States	Texas Oncology-Paris	Paris	Texas
United States	MultiCare Regional Cancer Center - Puyallup	Puyallup	Washington
United States	Providence Medical Foundation	Santa Rosa	California
United States	Medical Oncology Associates, PS (dba Summit Cancer Centers)	Spokane Valley	Washington
United States	MultiCare Institute for Research & Innovation	Tacoma	Washington
United States	MultiCare Regional Cancer Center - Tacoma	Tacoma	Washington
United States	Texas Oncology- Tyler	Tyler	Texas
United States	Ventura County Hematology-Oncology Specialists	Ventura	California
United States	Wenatchee Valley Hospital	Wenatchee	Washington
United States	Lutheran Medical Center	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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

External Links

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