Study of Intravenous TCD-717 in Patients With Advanced Solid Tumors
Summary
This is a Phase I dose escalation study of TCD-717, a novel drug that is a specific inhibitor of the enzyme choline kinase alpha, in patients with advanced solid tumors. The objectives of this study are to evaluate the safety of the drug and to determine the maximum tolerated dose and appropriate dose for phase II studies. Secondary objectives are to measure the efficacy of TCD-717; and in a substudy to be conducted in the MTD confirmation cohort only, to evaluate the potential correlation between the levels of tumor choline and tumor response to the choline kinase alpha inhibitor, TCD-717, using magnetic resonance spectroscopy. Pharmacokinetics analysis will be performed on patients enrolled in the maximum tolerated dose confirmation cohort.
Timeline
- Start
- 2011-01
- Primary completion
- 2014-02
- Completion
- 2014-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RSM-932A CATION | Small molecule | 2 mg/m2 | Intravenous |
| Subject | RSM-932A CATION | Small molecule | 4 mg/m2 | Intravenous |
| Subject | RSM-932A CATION | Small molecule | 7 mg/m2 | Intravenous |
| Subject | RSM-932A CATION | Small molecule | 10 mg/m2 | Intravenous |
| Subject | RSM-932A CATION | Small molecule | 14 mg/m2 | Intravenous |
| Subject | RSM-932A CATION | Small molecule | 19 mg/m2 | Intravenous |
| Subject | RSM-932A CATION | Small molecule | 25 mg/m2 | Intravenous |
| Subject | RSM-932A CATION | Small molecule | 31 mg/m2 | Intravenous |
| Subject | RSM-932A CATION | Small molecule | 39 mg/m2 | Intravenous |
| Subject | RSM-932A CATION | Small molecule | 49 mg/m2 | Intravenous |
| Subject | RSM-932A CATION | Small molecule | 61 mg/m2 | Intravenous |