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

NCT04803305

CompletedPhase 1

Sponsor: Pfizer

Conditions: Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Prostate Cancer, Breast Cancer

Interventions: PF-06946860, Placebo for PF-06946860

Countries: United States, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (33)
  • Little Rock, Arkansas, United States
  • Beverly Hills, California, United States
  • Camarillo, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Oxnard, California, United States
  • Santa Rosa, California, United States
  • Ventura, California, United States
  • Wheat Ridge, Colorado, United States
  • Fort Wayne, Indiana, United States
  • Bozeman, Montana, United States
  • Bozeman, Montana, United States
  • Bozeman, Montana, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Irving, Texas, United States
  • Longview, Texas, United States
  • Paris, Texas, United States
  • Tyler, Texas, United States
  • Charlottesville, Virginia, United States
  • Charlottesville, Virginia, United States
  • Charlottesville, Virginia, United States
  • Charlottesville, Virginia, United States
  • Auburn, Washington, United States
  • Gig Harbor, Washington, United States
  • Moses Lake, Washington, United States
  • Puyallup, Washington, United States
  • Spokane Valley, Washington, United States
  • Tacoma, Washington, United States
  • + 3 more on CT.gov