Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
2020-11-17
2022-03-30
2022-03-30
11
NCT04299048
Pfizer
Pfizer
INTERVENTIONAL
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
This 12-week open-label study will explore how PF-06946860 is tolerated, the effects of the study drug, the best dose for treatment and how participants with non-small cell lung, pancreatic or colorectal cancer and cachexia feel after receiving repeated subcutaneous dosing. During the 12-week treatment period, study drug will be administered subcutaneously every 3 weeks for a total of 5 doses. There is a 12-week follow-up period following the last dose of study drug. Additional assessments include: * body weight measurements * blood pressure and heart rate measurements * Lumbar Skeletal Muscle Index (LSMI) by CT scan * Blood samples: * to evaluate safety, * to measure the amount of the study drug in the blood, * to evaluate if the study drug causes an immune response, * to examine the effects of the study drug on levels of a specific cytokine, * and for exploratory samples for bio banking. * Measure the impact of the study drug on appetite, nausea, vomiting, fatigue, physical function, and health-related quality of life with questionnaires. * Measure the impact of study drug on physical activity using wearable digital sensors. * To evaluate the effect of study drug on ability to complete anti-tumor treatment and survival in participants with cancer and cachexia. * To evaluate tumor size.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-02-19 | 2023-03-09 | 2023-03-09 |
2020-03-04 | 2023-03-09 | 2023-12-14 |
2020-03-06 | 2023-12-14 | 2023-03 |
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: PF-06946860 subcutaneous injection | DRUG: PF-06946860
|
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Serum Unbound Trough Concentrations (Ctrough) of PF-06946860 | Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum unbound Ctrough was summarized by time and treatment group. | Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15 |
| Serum Total Ctrough of PF-06946860 | Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum total Ctrough was summarized by time and treatment group. | Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15 |
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications