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CompletedPhase 1NCT04803305
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPF-06946860 and Placebo for PF-06946860

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 12, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?33 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Pfizer
Interventions being studied
Drug: PF-06946860; Drug: Placebo for PF-06946860
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Key
  • 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • CARTI Cancer CenterLittle Rock, Arkansas
  • Tower Hematology Oncology Medical Group (THO)Beverly Hills, California
  • Ventura County Hematology- Oncology SpecialistsCamarillo, California
  • Cedars- Sinai Medical CenterLos Angeles, California
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos Angeles, California
  • Cedars-Sinai Medical CenterLos Angeles, California
  • Ventura County Hematology Oncology SpecialistsOxnard, California
  • Providence Medical FoundationSanta Rosa, California
  • Ventura County Hematology-Oncology SpecialistsVentura, California
  • Lutheran Medical CenterWheat Ridge, Colorado
  • Fort Wayne Medical Oncology and Hematology, Inc.Fort Wayne, Indiana
  • Bozeman Health Cancer CenterBozeman, Montana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 12, 2024. Always confirm current availability with the study team.

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