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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-111546 | Other Identifier | JAPIC |
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The purpose of this study is:
Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPB-31121 p1 | Experimental | Phase1 step |
|
| OPB-31121 p2 | Experimental | Phase2 step |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPB-31121 | Drug | Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With Treatment Emergent Adverse Events | Treatment emergent adverse events observed during outcome measure time frame. | From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32) |
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Recommended Dose (RD) of OPB-31121 was defined as the highest dose at which Dose Limited Toxicity (DLT) occurred at an incidence of < 30%. DLT was defined as adverse events related to OPB-31121 occurring until Day 32, and 1) Grade 4 neutrophil count decreased persisting for ≧ 8 days, or Grade 3 or 4 febrile neutropenia, or infection with neutrophil count decreased 2) Grade 4 Plt decreased, or Grade 3 Plt decreased persisting for ≧ 8 days 3) Grade 3 or 4 nausea, vomiting, or diarrhoea that occurred despite the use of an anti-emetic or anti-diarrheal agents 4) Grade 3 or more severe AEsa excluding the AEs presented above 1) to 3) 5) AEs requiring interruption of IMP administration for a period of ≧ 8 consecutive days 6) Same AEs causing interruption of IMP administration twice | From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32) |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response | Overall response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST guideline) - mRECIST 1.0. | From first dose of study medication up to 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | OPB-31121: 50mg/Day | OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle. |
| FG001 | OPB-31121: 100mg/Day | OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle |
| FG002 | OPB-31121: 200mg/Day | OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle |
| FG003 | OPB-31121: 400mg/Day | OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OPB-31121 | OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjects With Treatment Emergent Adverse Events | Treatment emergent adverse events observed during outcome measure time frame. | Safety population No statistical analysis provided for Subjects With Treatment Emergent Adverse Events. | Posted | Number | participants | From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32) |
|
|
From first study medication to end-of-trial examination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OPB-31121: 50 mg/Day | OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gait disturbance | General disorders | MedDRA Ver.16.0 | Systematic Assessment | General disorders and administration site conditions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA Ver.16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leader of Department of "Small Global" Clinical Development | Otsuka Pharmaceutical Co., Ltd | +81-3-6361-7366 |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| OPB-31121 phase2 | Drug | Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months) |
|
| Tokyo |
| Japan |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Definite progression of primary disease |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Recommended Dose (RD) of OPB-31121 was defined as the highest dose at which Dose Limited Toxicity (DLT) occurred at an incidence of < 30%. DLT was defined as adverse events related to OPB-31121 occurring until Day 32, and 1) Grade 4 neutrophil count decreased persisting for ≧ 8 days, or Grade 3 or 4 febrile neutropenia, or infection with neutrophil count decreased 2) Grade 4 Plt decreased, or Grade 3 Plt decreased persisting for ≧ 8 days 3) Grade 3 or 4 nausea, vomiting, or diarrhoea that occurred despite the use of an anti-emetic or anti-diarrheal agents 4) Grade 3 or more severe AEsa excluding the AEs presented above 1) to 3) 5) AEs requiring interruption of IMP administration for a period of ≧ 8 consecutive days 6) Same AEs causing interruption of IMP administration twice | DLT evaluated subjects who had achieved ≧75% study drug compliance during a 4-week (28-day) treatment period starting from Day 4. No statistical analysis provided for Subjects With DLTs. | Posted | Number | participants | From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32) |
|
|
|
| Secondary | Best Overall Response | Overall response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST guideline) - mRECIST 1.0. | Efficacy population included all treated subjects who had received at least 1 dose of study drug. No statistical analysis provided for Best Overall Responders. | Posted | Number | participants | From first dose of study medication up to 28 weeks |
|
|
|
| 0 |
| 7 |
| 7 |
| 7 |
| EG001 | OPB-31121: 100 mg/Day | OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle. | 0 | 4 | 4 | 4 |
| EG002 | OPB-31121: 200 mg/Day | OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle. | 0 | 7 | 7 | 7 |
| EG003 | OPB-31121: 400 mg/Day | OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle. | 2 | 5 | 5 | 5 |
|
| Jaundice | Hepatobiliary disorders | MedDRA Ver.16.0 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Ver.16.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Ver.16.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Ver.16.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA Ver.16.0 | Systematic Assessment |
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| Fatigue/malaise | Gastrointestinal disorders | MedDRA Ver.16.0 | Systematic Assessment | General disorders and administration site conditions |
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| Neutrophil count decreased | Investigations | MedDRA Ver.16.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA Ver.16.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA Ver.16.0 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Ver.16.0 | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| Title | Measurements |
|---|
|
| NE |
|