Safety, Tolerability, PK and PD Following SC PF-06946860 in Patients With NSCLC and Cachexia
Keywords
Abstract
Description
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 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 mass and 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 NSCLC and cachexia.
- To evaluate tumor size.
Dates
| Last Verified: | 02/29/2020 |
| First Submitted: | 02/18/2020 |
| Estimated Enrollment Submitted: | 03/03/2020 |
| First Posted: | 03/05/2020 |
| Last Update Submitted: | 04/12/2020 |
| Last Update Posted: | 04/13/2020 |
| Actual Study Start Date: | 03/31/2020 |
| Estimated Primary Completion Date: | 02/28/2021 |
| Estimated Study Completion Date: | 02/28/2021 |
Condition or disease
Intervention/treatment
Drug: subcutaneous injection
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: subcutaneous injection | Drug: subcutaneous injection subcutaneous injection |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Documented diagnosis of stage III or advanced metastatic stage IV NSCLC. - Cachexia, defined by BMI <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening or Involuntary weight loss of >5% within 6 months prior to screening irrespective of BMI or If medical record documentation is unavailable, patient's report will suffice to estimate involuntary body weight loss.; - Will receive platinum-based therapy with a platin + pemetrexed ± pembrolizumab or platin + nab paclitaxel ± pembrolizumab as first or second line therapy; and at the first cycle of platinum based therapy. - Adequate renal and liver function. - Signed informed consent. Exclusion Criteria: - Other forms of lung cancer - Cachexia caused by other reasons: Severe COPD requiring use of home O2, heart failure or AIDS. - known symptomatic brain metastases requiring steroids. - Active hepatitis B or C virus. - Confirmed positive HIV test. - Current active reversible causes of decreased food intake. - Receiving tube feedings or parenteral nutrition at Screening. - Elevated blood pressure that cannot be controlled by medications. - Women who are pregnant or breast-feeding |
Outcome
Primary Outcome Measures
1. safety and tolerability of repeated study drug administrations [24 weeks]
Secondary Outcome Measures
1. steady state free trough concentration [24 weeks]
2. steady state total trough concentration [24 weeks]
