Phase 1
N=18
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
Non-small Cell Lung Cancer · Pancreatic Cancer · Colorectal Cancer · Prostate Cancer · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04803305 ↗Enrolled (actual)
18
Serious AEs
30.6%
Results posted
Jan 2024
Primary outcome: Primary: Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A — 2.45; 1.84 Units on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-06946860 (Drug); Placebo for PF-06946860 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A |
2.45; 1.84 | — |
| SECONDARY Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A |
0.99; 2.19; 1.11; 2.21; 1.27; 2.30 | — |
| SECONDARY Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A |
1.84; 1.52; 0.04; -2.12; -1.21; -0.49 | — |
| SECONDARY Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A |
4; 7; 1; 3 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities in Part A |
2; 4; 2; 3; 1; 4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04803305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.