Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04803305|
Recruitment Status : Active, not recruiting
First Posted : March 17, 2021
Last Update Posted : July 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Pancreatic Cancer Colorectal Cancer Prostate Cancer Breast Cancer Ovarian Cancer Loss of Appetite Fatigue Cachexia Anorexia||Drug: PF-06946860 Drug: Placebo for PF-06946860||Phase 1|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Double-blind, sponsor open for 6-week double-blind treatment period followed by an optional 18-week open-label treatment period.|
|Official Title:||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|
|Actual Study Start Date :||May 11, 2021|
|Actual Primary Completion Date :||April 14, 2022|
|Estimated Study Completion Date :||August 15, 2022|
Experimental: Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment
Placebo Comparator: Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment
Drug: Placebo for PF-06946860
- effect of PF 06946860 compared to placebo on appetite [ Time Frame: Week 4 ]Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Appetite score based on 11-point numerical rating scale.
- effect of PF 06946860 compared to placebo on appetite [ Time Frame: Weeks 1, 2, 3, 5 and 6 ]Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Appetite score based on 11-point numerical rating scale.
- effect of PF 06946860 compared to placebo on fatigue [ Time Frame: Weeks 1, 2, 3, 4, 5 and 6. ]Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Fatigue score based on 11-point numerical rating scale.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Week 6 ]Incidence of adverse events
- Incidence of laboratory abnormalities [Safety and Tolerability] [ Time Frame: Week 6 ]Incidence of laboratory abnormalities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803305
|Study Director:||Pfizer CT.gov Call Center||Pfizer|