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

Pfizer

Status and phase: Completed; Phase 1

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

Treatments: Drug: PF-06946860; Drug: Placebo for PF-06946860

Study type: Interventional

Funder types: Industry

Identifiers

NCT04803305

C3651010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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18 participants in 2 patient groups, including a placebo group

Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment

Experimental group

Description:

subcutaneous injection

Treatment:

Drug: PF-06946860

Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment

Placebo Comparator group

Description:

subcutaneous injection

Treatment:

Drug: Placebo for PF-06946860

Drug: PF-06946860