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

• Status: Recruiting
• Trial end date: 2022-06-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

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 incurable.

• Anorexia as defined by a score of ≤5 in the Cancer-Related Cachexia Symptom Assessment Appetite 7-day recall scale

• Meets any 1 of the following criteria at Randomization:

• Not currently receiving antineoplastic therapy

• On third line systemic antineoplastic therapy

• Receiving chemotherapy or immunotherapy treatment which is considered to be without curative intent.

• On a stable regimen of systemic antineoplastic therapy.

• Signed informed consent.

Key Exclusion Criteria:

• Other forms of cancer not listed in Inclusion Criterion for which treatment has been received in the past 6 months

• 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. Confirmed positive test for HIV.

• Elevated blood pressure uncontrolled by medications.

• inadequate renal or liver function.

• Women who are pregnant or breast-feeding