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

NCT01684202 | Completed Phase 2 Results

• 2 other identifiers: 156-12-001JapicCTI-121957
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinomatous Edema

Outcome Measures

Primary Outcomes (2)

• Change in Body Weight From Baseline at Final IMP Administration

  Body weight was measured in 100-g units before breakfast and after subjects had urinated at least once, taking care to minimize fluctuations due to defecation or clothing.

  Baseline, at the final IMP administration (shortest:7days longest:12days)

• Change in Ascites Volume From Baseline Measured by Computer Tomography (CT) at Final IMP Administration

  Baseline, at the final IMP administration (shortest:7days longest:12days)

Study Arms (1)

OPC-41061

EXPERIMENTAL

Drug: OPC-41061

Interventions

OPC-41061 DRUG

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

OPC-41061

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects judged as having cancer by biopsy or cytology
• Subjects with carcinomatous ascites
• Male or female subjects between the ages of 20 and 80, inclusive (at time of informed consent)
• Subjects with survival expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) Performance Status score (PS score) of 0 to 2
• Subjects who are inpatients or who can be admitted to the trial site for the duration of the trial
• Subjects who, together with their partner, are able to practice one of the specified contraceptive methods until 4 weeks after final trial drug administration
• Subjects capable of giving informed consent to participate in the trial of their own free will prior to start of the trial.

You may not qualify if:

• Subjects with any of the following complications or symptoms:
• Deep vein thrombosis
• Intestinal obstruction or intestinal edema with symptoms similar to intestinal obstruction
• Hepatic cirrhosis
• Anuria
• Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
• Continuing symptoms of diarrhea or vomiting
• Infection requiring systemic treatment
• Subjects with any of the following medical histories:
• History of cerebrovascular disorder or coronary disease within 4 weeks prior to start of the pre-observation period
• History of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride
• History of gastrectomy or enterectomy to an extent affecting absorption of oral medication
• Subjects with any of the following abnormal laboratory values:
• Platelet count of \< 75,000/mm3, hemoglobin of \< 8.0 g/dL, neutrophil count of \< 1,000/mm3, total bilirubin of \> 4.0 g/dL, serum creatinine of \> 3.0 mg/dL, serum sodium of \> 147 mEq/L, or serum potassium of \> 5.5 mEq/L
• Subjects who have used albumin products (agents for treating hypoalbuminemia) or blood products containing albumins within 1 week prior to start of the pre-observation period, or after start of the pre-observation period

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kansai Region, Japan

Location

MeSH Terms

Interventions

Tolvaptan

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Junichi Hahimoto, PhD

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: September 12, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: March 18, 2021
• Results First Posted: March 18, 2021

Record last verified: 2021-02

Locations

JP (1)