Full TitleA Phase 1, Dose Escalation Study of Intravenous TK216 in Patients with Relapsed or Refractory Ewing Sarcoma (TK216-01) (Version 3 - Amendment 2- Date: 02-NOV-2016)
The purpose of this study is to find the highest dose of the investigational drug TK216 that can be given safely in patients with Ewing sarcoma that has come back after therapy or stopped responding to treatment. Ewing sarcoma arises from a “switch” between two chromosomes. This genetic alteration produces a factor that binds to DNA in many locations and converts normal cells into cancer cells. TK216 prevents the binding of this factor to other partners, which Ewing sarcoma needs to grow.
TK216 is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have Ewing sarcoma that has come back or continued to grow despite prior therapy.
- Patients may have had up to four prior regimens of therapy and must recover from any serious side effects before entering the study.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 12 and older.