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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: PF-06946860
* Drug: Placebo for PF-06946860


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment<br>subcutaneous injection | Drug: PF-06946860<br>* subcutaneous injection<br>|
| Placebo Comparator: Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment<br>subcutaneous injection | Drug: PF-06946860<br>* subcutaneous injection<br>Drug: Placebo for PF-06946860<br>* subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of PF 06946860 compared to placebo on appetite | Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Appetite score based on 11-point numerical rating scale. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of PF 06946860 compared to placebo on appetite | Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Appetite score based on 11-point numerical rating scale. | Weeks 1, 2, 3, 5 and 6 | 
| effect of PF 06946860 compared to placebo on fatigue | Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Fatigue score based on 11-point numerical rating scale. | Weeks 1, 2, 3, 4, 5 and 6. | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of adverse events | Week 6 | 
| Incidence of laboratory abnormalities [Safety and Tolerability] | Incidence of laboratory abnormalities | Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue