Conditions: Carcinomatous Edema
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 43
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: OPC-41061
Intervention descriptions: intervention 1: orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days.

Protocol document: