drugset / Trial / NCT01606345
Phase I Study of Percutaneous Valrubicin for Upper Tract Urothelial Carcinoma
Phase 1
Completed
4 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Endo USA Inc., a Keenova Therapeutics Company · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to learn more about how well the drug valrubicin (VALSTAR®) works to help treat the patient's cancer when administered through a nephrostomy tube inserted through their back into their kidney. The study is also being done to determine how safe and easy it is to tolerate valrubicin at specific dose levels, as well as the way in which the drug is eliminated from the human body (Pharmacokinetics or PK).
Timeline
- Start
- 2012-07
- Primary completion
- 2016-04
- Completion
- 2016-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Valrubicin | Small molecule | 200 mg | Other |
| Subject | Valrubicin | Small molecule | 400 mg | Other |
| Subject | Valrubicin | Small molecule | 800 mg | Other |