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)

NCT01684202, Phase 2, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2021-03-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2). Trials, record NCT01684202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01684202

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

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)
NCT number: NCT01684202
Status: Completed
Phases: Phase 2
Enrollment: 43 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Carcinomatous Edema
Interventions: OPC-41061
First posted: 2012-09-12
Last updated: 2021-03-18
Results first posted: 2021-03-18

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Body Weight From Baseline at Final IMP Administration	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.
Primary	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)

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Body Weight From Baseline at Final IMP Administration	Baseline, at the final IMP administration (shortest:7days longest:12days)	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.	Kg	MEAN
PRIMARY	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)	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.	mL	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Body Weight From Baseline at Final IMP Administration	OPC-41061 3.75 mg	-0.69	Standard Deviation 2.51	Kg
Change in Body Weight From Baseline at Final IMP Administration	OPC-41061 7.5 mg	-0.34	Standard Deviation 1.99	Kg
Change in Body Weight From Baseline at Final IMP Administration	OPC-41061 15 mg	-1.13	Standard Deviation 1.62	Kg
Change in Body Weight From Baseline at Final IMP Administration	OPC-41061 30 mg	0.70	Standard Deviation 1.56	Kg
Change in Ascites Volume From Baseline Measured by Computer Tomography (CT) at Final IMP Administration	OPC-41061 3.75 mg	-77.20	Standard Deviation 982.19	mL
Change in Ascites Volume From Baseline Measured by Computer Tomography (CT) at Final IMP Administration	OPC-41061 7.5 mg	513.97	Standard Deviation 653.30	mL
Change in Ascites Volume From Baseline Measured by Computer Tomography (CT) at Final IMP Administration	OPC-41061 15 mg	153.72	Standard Deviation 993.63	mL
Change in Ascites Volume From Baseline Measured by Computer Tomography (CT) at Final IMP Administration	OPC-41061 30 mg	539.93	Standard Deviation 659.36	mL

Source ClinicalTrials.gov

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Dose-escalation Period	STARTED	OPC-41061 3.75 mg	15
Dose-escalation Period	STARTED	OPC-41061 7.5 mg	8
Dose-escalation Period	STARTED	OPC-41061 15 mg	9
Dose-escalation Period	STARTED	OPC-41061 30 mg	11
Dose-escalation Period	COMPLETED	OPC-41061 3.75 mg	14
Dose-escalation Period	COMPLETED	OPC-41061 7.5 mg	7
Dose-escalation Period	COMPLETED	OPC-41061 15 mg	9
Dose-escalation Period	COMPLETED	OPC-41061 30 mg	11
Dose-escalation Period	NOT COMPLETED	OPC-41061 3.75 mg	1
Dose-escalation Period	NOT COMPLETED	OPC-41061 7.5 mg	1

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events232

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Leukopenia	Blood and lymphatic system disorders	OPC-41061 3.75 mg	0	15
other	Leukopenia	Blood and lymphatic system disorders	OPC-41061 7.5 mg	1	8
other	Leukopenia	Blood and lymphatic system disorders	OPC-41061 15 mg	0	9
other	Leukopenia	Blood and lymphatic system disorders	OPC-41061 30 mg	0	11
other	Neutropenia	Blood and lymphatic system disorders	OPC-41061 3.75 mg	0	15
other	Neutropenia	Blood and lymphatic system disorders	OPC-41061 7.5 mg	1	8
other	Neutropenia	Blood and lymphatic system disorders	OPC-41061 15 mg	1	9
other	Neutropenia	Blood and lymphatic system disorders	OPC-41061 30 mg	0	11
other	Thrombocytopenia	Blood and lymphatic system disorders	OPC-41061 3.75 mg	0	15
other	Thrombocytopenia	Blood and lymphatic system disorders	OPC-41061 7.5 mg	1	8

1 to 10 of 232Source ClinicalTrials.gov

See all 232 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	OPC-41061 3.75 mg	0	15
Total, all-cause mortality	OPC-41061 7.5 mg	0	8
Total, all-cause mortality	OPC-41061 15 mg	0	9
Total, all-cause mortality	OPC-41061 30 mg	0	11
Total, other adverse events	OPC-41061 3.75 mg	8	15
Total, other adverse events	OPC-41061 7.5 mg	6	8
Total, other adverse events	OPC-41061 15 mg	8	9
Total, other adverse events	OPC-41061 30 mg	10	11
Total, serious adverse events	OPC-41061 3.75 mg	1	15
Total, serious adverse events	OPC-41061 7.5 mg	0	8

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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