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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04803305
Other study ID # C3651010
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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