Clinical Trial TitleC3651009: A Phase 1B, 12-week, Open-label Study to Assess Safety Tolerability, Pharmacokinetics & Pharmocodynamics Following Repeated Subcutaneous Administrations of PF-06946860 in Patients with NSCLC & Cachexia
National Clinical Trial Number:NCT04299048
Clinical Trial Protocol Description:
Study is to explore how the investigational new drug (PF-06946860) is tolerated, the effects of the study drug, the best dose for treatment and how participants with NSCLC and cachexia feel after receiving repeated subcutaneous (SC-injected under the skin) dosing.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have documented histologic or cytologic diagnosis of NSCLC by American Joint Committee on Cancer (AJCC) criteria, and determined to be stage III or advanced metastatic stage IV disease.
- Have serum GDF-15 levels of ≥1.5 ng/mL (as measured using the IUO Roche Elecsys GDF-15 assay) at screening.
You will be excluded from the study if any of the following criteria apply to you:
- Have known symptomatic brain metastases requiring steroids.
- Have had any of the following in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsade de Pointes, arrhythmias (including sustained ventricular tachyarrhythmiaand ventricular fibrillation), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism or other clinical significant episode of thrombo embolic disease.
- Have undergone major surgery within 4 weeks prior to randomization.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.