drugset / Trial / NCT01337505
Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450 mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous infusion on Day 1 every 21 days for up to 6 cycles.
Timeline
- Start
- 2011-04
- Primary completion
- 2012-09
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aldoxorubicin | Small molecule | 230 mg/m2 | Intravenous |
| Subject | Aldoxorubicin | Small molecule | 350 mg/m2 | Intravenous |
| Subject | Aldoxorubicin | Small molecule | 450 mg/m2 | Intravenous |