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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

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 1, 2, 3, 4, 5 and 6

Summary

This trial tests a new drug to improve appetite in advanced cancer patients with anorexia. The drug is given through injections under the skin. The study measures changes in appetite, fatigue, pain, body weight, and blood markers.

Eligible Conditions
  • Cachexia
  • Prostate Cancer
  • Breast Cancer
  • Anorexia
  • Lung Cancer
  • Fatigue
  • Ovarian Cancer
  • Fatigue and Malaise
  • Pancreatic Cancer
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 1, 2, 3, 4, 5 and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 1, 2, 3, 4, 5 and 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A
Secondary study objectives
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A
+1 more

Side effects data

From 2022 Phase 1 trial • 11 Patients • NCT04299048
50%
Anaemia
50%
Diarrhoea
40%
Nausea
40%
Fatigue
20%
Lacrimation increased
20%
Insomnia
20%
Fall
20%
Dizziness
20%
Hypertension
20%
Platelet count decreased
20%
Dehydration
20%
Neutrophil count decreased
20%
Hypokalaemia
20%
Abdominal pain upper
20%
Vomiting
10%
Malignant neoplasm progression
10%
Dysuria
10%
Hypocalcaemia
10%
Electrocardiogram Q wave abnormal
10%
Hypoalbuminaemia
10%
Proteinuria
10%
Conjunctivitis
10%
Abdominal distension
10%
Hyperglycaemia
10%
Hypoaesthesia
10%
Depression
10%
Decreased appetite
10%
Hypomagnesaemia
10%
Contusion
10%
Dysgeusia
10%
Myalgia
10%
Back pain
10%
Asthenia
10%
Cough
10%
Muscular weakness
10%
Hypoxia
10%
Epigastric discomfort
10%
Blood alkaline phosphatase increased
10%
Confusional state
10%
Upper-airway cough syndrome
10%
Haematuria
10%
Head discomfort
10%
Rash macular
10%
Conjunctival hyperaemia
10%
Aspartate aminotransferase increased
10%
Epistaxis
10%
Skin laceration
10%
Alanine aminotransferase increased
10%
Anxiety
10%
Paraesthesia
10%
Ataxia
10%
Oral contusion
10%
Sepsis
10%
Monocytosis
10%
Sinus tachycardia
10%
Cholecystitis acute
10%
Hypothyroidism
10%
Transaminases increased
10%
Abdominal discomfort
10%
COVID-19
10%
Upper respiratory tract infection
10%
Urinary tract infection
10%
Blood bilirubin increased
10%
Thrombocytopenia
10%
Thrombocytosis
10%
Abdominal pain
10%
Oral pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
PF-06946860 Q3W

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 TreatmentExperimental Treatment1 Intervention
subcutaneous injection
Group II: Double-Blind Placebo Treatment followed by Open-Label PF-06946860 TreatmentPlacebo Group2 Interventions
subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06946860
2019
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,669 Previous Clinical Trials
17,861,906 Total Patients Enrolled
3 Trials studying Cachexia
242 Patients Enrolled for Cachexia
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,902,908 Total Patients Enrolled
3 Trials studying Cachexia
242 Patients Enrolled for Cachexia
~4 spots leftby Dec 2025
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