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
Verified date | April 2023 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Canada,
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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