CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
OPC-41061drug
Likely dose
OPC-41061 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 daysAI-extracted
Key inclusion· 6
  • Confirmed cancer diagnosis by biopsy or cytology
  • Presence of carcinomatous ascites
  • Age 20–80 years at time of informed consent
  • ECOG Performance Status 0–2 with ≥3 months survival expectancy
Key exclusion· 13
  • Active infection requiring systemic treatment
  • Deep vein thrombosis
  • Intestinal obstruction or intestinal edema with symptoms similar to intestinal obstruction
  • Hepatic cirrhosis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

In the news

1 article

Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.

Search/NCT01684202
NCT01684202Phase 2Completed

A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2)

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Sep 12, 2012·Updated Mar 18, 2021

In Brief

A Phase 2 clinical trial evaluating OPC-41061 for Carcinomatous Edema. Completed, enrolled 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 12, 2012
Enrollment StartJul 1, 2012
Primary CompletionDec 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.8 years ago

Interventions

OPC-41061drug

orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days.