Trials / Completed
CompletedNCT04803305
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
A 6-WEEK, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN STUDY TO ASSESS THE EFFECT OF REPEATED SUBCUTANEOUS ADMINISTRATION OF PF-06946860 ON APPETITE IN PARTICIPANTS WITH ADVANCED CANCER AND ANOREXIA, FOLLOWED BY AN 18-WEEK OPEN-LABEL TREATMENT PERIOD
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 receiving repeated doses injected under the skin (subcutaneously). During the initial 6-week treatment period (Part A), a total of 2 doses of study drug or placebo will be administered 3 weeks apart. Each dose contains two injections. Part B is an optional 18-week open-label treatment period where up to 7 doses of study drug may be administered. Part B does not include placebo. Assessments include: * Measure the impact of the study drug on appetite, fatigue, and pain questionnaires * Body weight measurements * Blood samples to evaluate safety and additional endpoints including the amount of the study drug in the blood and the effects of the study drug on levels of a specific cytokine.
Conditions
- Non-small Cell Lung Cancer
- Pancreatic Cancer
- Colorectal Cancer
- Prostate Cancer
- Breast Cancer
- Ovarian Cancer
- Loss of Appetite
- Fatigue
- Cachexia
- Anorexia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-06946860 | subcutaneous injection |
| DRUG | Placebo for PF-06946860 | subcutaneous injection |
Timeline
- Start date
- 2021-05-11
- Primary completion
- 2022-04-14
- Completion
- 2022-08-09
- First posted
- 2021-03-17
- Last updated
- 2024-01-12
- Results posted
- 2024-01-12
Locations
33 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04803305. Inclusion in this directory is not an endorsement.