Clinical Trial TitleA study of TL-895 with standard available treatment versus standard available treatment for the treatment of COVID-19 in patients with cancer.
National Clinical Trial Number:NCT04419623
Clinical Trial Protocol Description:
This study evaluates TL-895, a tyrosine kinase inhibitor. The specific kinase inhibited or blocked by the study drug is believed to help decrease lung inflammation by shutting down signals involved with the release of inflammation. It is believed that this inhibitor drug may reduce the need to use a ventilator. This is a 2-part study comprising a Phase 1 safety lead-in (Part 1) that will determine the recommended TL-895 dose for Phase 2 (Part 2).
In Part 1, TL-895 open-label will be administered orally at an assigned dose continuously in 7-day cycles for 2 cycles. Up to 3 dose levels will be evaluated.
In Part 2, eligible subjects will be randomized in a 1:1 ratio to TL-895 with standard available treatment (SAT), or placebo with SAT. Investigators and Sponsor will be blinded to each subject's assigned study intervention throughout the course of the study.
The study will consist of a Screening Period of up to 10 days, a Treatment Period (7-day cycles), and a Follow-up Visit in both phases of the study. The study is expected to be approximately 12 months in duration.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are a least 18 years or older and have a diagnosis of active cancer that is not considered cured or disease free.
- Have a confirmed COVID-19 infection.
- Have adequate body and organ function.
- Are able to swallow pills.
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.