- ICH GCP
- US Clinical Trials Registry
- Clinical 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)
February 24, 2021 updated by: Otsuka Pharmaceutical Co., Ltd.
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 Overview
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kansai Region, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
- Subjects who have received any investigational drug within 4 weeks prior to start of the pre-observation period
- Subjects who have previously received OPC-41061
- Subjects who have received surgical treatment or radiation therapy for cancer within 4 weeks prior to start of the pre-observation period
- Subjects for whom the investigator or subinvestigator judges that it would be difficult to evaluate the efficacy and safety of OPC-41061 due to the effects of ongoing chemotherapy or other therapies for cancer (eg, improvement of carcinomatous ascites or development of edema due to adverse events related to therapeutic interventions other than OPC-41061)
- Subjects who are unable to sense thirst or who have difficulty with fluid or food intake
- Subjects who are unable to take oral medication
- Female subjects who are pregnant, possibly pregnant, or nursing, or who plan to become pregnant during the trial period Subjects otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: OPC-41061
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orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Weight From Baseline at Final IMP Administration
Time Frame: Baseline, at the final IMP administration (shortest:7days longest:12days)
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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.
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Baseline, at the final IMP administration (shortest:7days longest:12days)
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Change in Ascites Volume From Baseline Measured by Computer Tomography (CT) at Final IMP Administration
Time Frame: Baseline, at the final IMP administration (shortest:7days longest:12days)
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Baseline, at the final IMP administration (shortest:7days longest:12days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Junichi Hahimoto, PhD, Otsuka Pharmaceutical Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (ACTUAL)
December 1, 2013
Study Completion (ACTUAL)
June 1, 2014
Study Registration Dates
First Submitted
September 10, 2012
First Submitted That Met QC Criteria
September 10, 2012
First Posted (ESTIMATE)
September 12, 2012
Study Record Updates
Last Update Posted (ACTUAL)
March 18, 2021
Last Update Submitted That Met QC Criteria
February 24, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 156-12-001
- JapicCTI-121957 (OTHER: JAPIC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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