Status:
COMPLETED
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
Lead Sponsor:
Pfizer
Conditions:
Non-small Cell Lung Cancer
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 su...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04803305
Start Date
May 11 2021
End Date
August 9 2022
Last Update
January 12 2024
Active Locations (33)
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1
CARTI Cancer Center
Little Rock, Arkansas, United States, 72205
2
Tower Hematology Oncology Medical Group (THO)
Beverly Hills, California, United States, 90211
3
Ventura County Hematology- Oncology Specialists
Camarillo, California, United States, 93010
4
Cedars- Sinai Medical Center
Los Angeles, California, United States, 90048