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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01684202
First received: September 10, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Carcinomatous Edema
Drug: OPC-41061
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2)

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • body weight [ Time Frame: The day after completion of study treatment with investigational drug (shortest:7days longest:12days) ] [ Designated as safety issue: No ]
    Change from baseline (Kg)

  • ascites [ Time Frame: The day after completion of study treatment with investigational drug(shortest:7days longest:12days) ] [ Designated as safety issue: No ]
    Change from baseline assessed by computer tomography (mL)

  • body weight [ Time Frame: The day after completion of study treatment with investigational drug (shortest:7days longest:12days) ] [ Designated as safety issue: No ]
    Percent change from baseline (%)

  • ascites [ Time Frame: The day after completion of study treatment with investigational drug(shortest:7days longest:12days) ] [ Designated as safety issue: No ]
    Percent change from baseline assessed by computer tomography (mL)


Enrollment: 43
Study Start Date: July 2012
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPC-41061 Drug: OPC-41061
orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684202

Locations
Japan
Kansai Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Junichi Hahimoto, PhD Otsuka Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01684202     History of Changes
Other Study ID Numbers: 156-12-001, JapicCTI-121957
Study First Received: September 10, 2012
Last Updated: July 7, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Edema
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014