Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nutritional and Metabolic Diseases

Rare Diseases

Fatigue

Breast Neoplasms

Pancreatic Neoplasms

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Body Weight

Anorexia

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Weight Loss

Wasting Syndrome

Cachexia

Syndrome

Signs and Symptoms, Digestive

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

PF-06946860

Placebo for PF-06946860

Pfizer CT.gov Call Center

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.

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.

Double-blind, sponsor open for 6-week double-blind treatment period followed by an optional 18-week open-label treatment period.

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

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.

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.

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.

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.

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.

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 \[/low power field (LPF)\]).

Pfizer

The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.

Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.

Placebo

Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.

PF-06946860 200mg Q3W

Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.

Placebo -> OL PF-06946860 200mg Q3W

Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.

PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W

Total

Age, Continuous

18-44

45-64

>=65

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black or African American

Asian

Race/Ethnicity, Customized

The baseline analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Pfizer ClinicalTrials.gov Call Center

The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed/number analyzed = number of participants evaluable for this OM in each treatment group.

Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A

Week 1

Week 2

Week 3

Week 5

Week 6

The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed at each timepoint in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed = number of participants evaluable for this OM, number analyzed = number of participants evaluable at each timepoint for each treatment group.

Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A

Week 4

Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A

Participants With All-Causality TEAEs

Participants With All-Causality SAEs

The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A

Hemoglobin <0.8 x lower limit of normal (LLN)

Hematocrit <0.8 x LLN

Erythrocytes <0.8 x LLN

Erythrocytes Mean Corpuscular Volume <0.9 x LLN

Erythrocytes Mean Corpuscular Volume >1.1 x upper limit of normal (ULN)

Erythrocytes Mean Corpuscular Hemoglobin <0.9 x LLN

Erythrocytes Mean Corpuscular Hemoglobin >1.1 x ULN

Erythrocytes Mean Corpuscular Hemoglobin Concentration <0.9 x LLN

Erythrocytes Mean Corpuscular Hemoglobin Concentration >1.1 x ULN

Platelets <0.5 x LLN

Platelets >1.75 x ULN

Leukocytes <0.6 x LLN

Leukocytes >1.5 x ULN

Lymphocytes <0.8 x LLN

Lymphocytes >1.2 x ULN

Basophils >1.2 x ULN

Eosinophils >1.2 x ULN

Monocytes >1.2 x ULN

Bilirubin >1.5 x ULN

Aspartate Aminotransferase >3.0 x ULN

Alanine Aminotransferase >3.0 x ULN

Alkaline Phosphatase >3.0 x ULN

Protein <0.8 x LLN

Protein >1.2 x ULN

Albumin <0.8 x LLN

Albumin >1.2 x ULN

Blood Urea Nitrogen >1.3 x ULN

Creatinine >1.3 x ULN

Urate >1.2 x ULN

Sodium <0.95 x LLN

Sodium >1.05 x ULN

Potassium <0.9 x LLN

Potassium >1.1 x ULN

Chloride <0.9 x LLN

Chloride >1.1 x ULN

Calcium <0.9 x LLN

Calcium >1.1 x ULN

Bicarbonate <0.9 x LLN

Bicarbonate >1.1 x ULN

Glucose <0.6 x LLN

Glucose >1.5 x ULN

pH <4.5

pH >8

Urine Glucose >=1

Ketones >=1

Urine Protein >=1

Urine Hemoglobin >=1

Urobilinogen >=1

Urine Bilirubin >=1

Nitrite >=1

Leukocyte Esterase >=1

Urine Erythrocytes (/HPF) >=20

Urine Leukocytes (/HPF) >=20

Hyaline Casts (/LPF) >1

PF- 06946860 200mg Q3W

The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention, with at least one observation of the given laboratory test while on study treatment or during lag time.

Number of Participants With Laboratory Test Abnormalities in Part A

Participants received placebo during the 6-week double-blind phase (Part A) 3 weeks apart (Q3W) subcutaneously (SC). Starting at the Week 6 visit, participants who continued to the optional open-label treatment (OLT) period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.

Part A: 6-week Double-blind Treatment

Part B: OLT Period up to 18 Weeks

Spots Global Cancer Trial Database for cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue