drugset / Trial / NCT01684202
A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2)
NaSingle-groupOpen-labelTreatment
Summary
OPC-41061 will be administered to patients with volume overload associated with cancer, first by dose-escalation and subsequently for 6 consecutive days at the fixed dose at which urine volume is increased to investigate efficacy, pharmacokinetics, pharmacodynamic effects, and safety and to determine the effective initial and maintenance doses of OPC-41061.
Timeline
- Start
- 2012-07
- Primary completion
- 2013-12
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolvaptan | Small molecule | 3.75 mg | Oral |
| Subject | Tolvaptan | Small molecule | 7.5 mg | Oral |
| Subject | Tolvaptan | Small molecule | 15 mg | Oral |
| Subject | Tolvaptan | Small molecule | 30 mg | Oral |