drugset / Trial / NCT04199026
Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma
NaSingle-groupOpen-labelDevice feasibility
Summary
This early phase I trial studies the side effects of implanting and removing a microdevice in patients with sarcomas that have spread to other places in the body (metastatic) or have come back (recurrent). Microdevices are rice-sized devices that are implanted into tumor tissue and are loaded with 10 different drugs that are delivered at very small doses, or "microdoses," which may only affect a very small, local area inside the tumor. The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.
Timeline
- Start
- 2025-02-25
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | — | Other |
| Subject | Everolimus | Small molecule | — | Other |
| Subject | Ganitumab | Monoclonal antibody | — | Other |
| Subject | Ifosfamide | Small molecule | — | Other |
| Subject | Irinotecan | Small molecule | — | Other |
| Subject | Pazopanib | Small molecule | — | Other |
| Subject | Temozolomide | Small molecule | — | Other |
| Subject | Temsirolimus | Small molecule | — | Other |
| Subject | Vincristine | Small molecule | — | Other |
| Subject | polyethylene glycol | Other / unclassified | — | Other |