Carcinomatous EdemaPhase 2NCT01684202

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

A Phase 2 study testing OPC-41061 in people with Carcinomatous Edema, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Carcinomatous Edema
What is being tested?: OPC-41061
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteJapan
Study dates: Jul 2012to Jun 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 22Show fewer

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Kansai Region

Other trials in Japan

About this study

Conditions: Carcinomatous Edema
Being tested: OPC-41061

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPC-41061Drug
orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days.

Study groups in NCT01684202
Study group	Role	What they receive
OPC-41061	Experimental	Not described Receives: Drug: OPC-41061

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Jun 2014

First posted12 Sep 2012 (estimated)
Study startJul 2012
Primary completionDec 2013
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carcinomatous EdemaStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01684202
Sponsor's protocol ID: 156-12-001
Other IDs: JapicCTI-121957
Status last verified: Feb 2021
First submitted: 10 Sep 2012
Last updated: 18 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01684202
Acronym / sponsor ID: 156-12-001
Conditions: Carcinomatous Edema
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Dec 2013 (actual)
Study completion: Jun 2014 (actual)
First posted: 12 Sep 2012 (estimated)
Results: Posted 18 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OPC-41061	Experimental	Drug: OPC-41061

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (22 listed)

Subjects with any of the following complications or symptoms:
Subjects with any of the following medical histories:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OPC-41061orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days.	Drug	OPC-41061

Primary outcome

Change in Body Weight From Baseline at Final IMP Administration
Time frame: Baseline, at the final IMP administration (shortest:7days longest:12days)
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.
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)

Results and safety

Results posted to the registry on 18 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OPC-41061 3.75 mg	15	14
OPC-41061 7.5 mg	8	7
OPC-41061 15 mg	9	9
OPC-41061 30 mg	11	11

Primary outcome: Change in Body Weight From Baseline at Final IMP Administration

Time frame: Baseline, at the final IMP administration (shortest:7days longest:12days). Mean (Standard Deviation). Unit: Kg

Measure	OPC-41061 3.75 mg n = 13	OPC-41061 7.5 mg n = 7	OPC-41061 15 mg n = 9	OPC-41061 30 mg n = 11
Value	-0.69 (2.51)	-0.34 (1.99)	-1.13 (1.62)	0.70 (1.56)

Population analysed: Full analysis set: all subjects who had been administered the IMP at least once and from whom data for efficacy endpoints were obtained after the start of IMP administration.

Primary outcome: 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). Mean (Standard Deviation). Unit: mL

Measure	OPC-41061 3.75 mg n = 11	OPC-41061 7.5 mg n = 4	OPC-41061 15 mg n = 8	OPC-41061 30 mg n = 10
Value	-77.20 (982.19)	513.97 (653.30)	153.72 (993.63)	539.93 (659.36)

Population analysed: Full analysis set: all subjects who had been administered the IMP at least once and from whom data for efficacy endpoints were obtained after the start of IMP administration.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPC-41061 3.75 mg	1 of 15 (6.7%)	8 of 15 (53.3%)	0 of 15
OPC-41061 7.5 mg	0 of 8 (0%)	6 of 8 (75%)	0 of 8
OPC-41061 15 mg	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9
OPC-41061 30 mg	0 of 11 (0%)	10 of 11 (90.9%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Junichi Hahimoto, PhD study director

Otsuka Pharmaceutical Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OPC-41061 in people with Carcinomatous Edema, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Weight From Baseline at Final IMP Administration (time frame: Baseline, at the final IMP administration (shortest:7days longest:12days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01684202.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.