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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-111478 | Other Identifier | JAPIC |
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To determine the maximum tolerated dose (MTD) of OPB-51602
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPB-51602 | Experimental | OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPB-51602 | Drug | once daily during the treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With Treatment Emergent Adverse Events | Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration. | From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31) |
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia). | From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Response | Assessment of the treatment response was evaluated according to internationally recognized response criteria for multiple myeloma, non-Hodgkin's lymphoma, acute myeloid leukemia, chronic myeloid leukemia. "Response" was defined as at least partial response or partial remission (PR) according to the criteria for efficacy assessment. | From first dose of study medication to withdrawal examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | OPB-51602: 1mg/Day | OPB-51602: 1, 2, 3,4 and 6 mg/day oral once daily (QD) in a 4 week cycle |
| FG001 | OPB-51602: 2mg/Day | OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle |
| FG002 | OPB-51602: 3mg/Day | OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle |
| FG003 | OPB-51602: 4mg/Day | OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle |
| FG004 | OPB-51602: 6mg/Day | OPB-51602: 1, 2, 3, 4 and 6 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-51602 | OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle OPB-51602: once daily during the treatment period |
| 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. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration. | Safety population No statistical analysis provided for Subjects With Treatment Emergent Adverse Events. | Posted | Number | participants | From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31) |
|
|
From first dose of study medication to 30 days after last dose of study medication.
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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-51602 1mg/Day | OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Ver.16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | 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 |
|---|---|
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| Tokyo |
| Japan |
| 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 |
|
| Participants |
|
|
| Secondary | Treatment Response | Assessment of the treatment response was evaluated according to internationally recognized response criteria for multiple myeloma, non-Hodgkin's lymphoma, acute myeloid leukemia, chronic myeloid leukemia. "Response" was defined as at least partial response or partial remission (PR) according to the criteria for efficacy assessment. | Efficacy population included all treated subjects who had received at least 1 dose of study drug. No statistical analysis provided for treatment response. | Posted | Number | participants | From first dose of study medication to withdrawal examination |
|
|
|
| Primary | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia). | 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 31 (after repeated 28 days medication from Day 4 to 31) |
|
|
|
| 1 |
| 4 |
| 4 |
| 4 |
| EG001 | OPB-51602 2mg/Day | OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle | 0 | 3 | 3 | 3 |
| EG002 | OPB-51602 3mg/Day | OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle | 2 | 4 | 4 | 4 |
| EG003 | OPB-51602 4mg/Day | OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle | 0 | 6 | 6 | 6 |
| EG004 | OPB-51602 6mg/Day | OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle | 0 | 3 | 3 | 3 |
| Fatigue | General disorders | MedDRA Ver.16.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA Ver.16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Ver.16.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Ver.16.0 | Systematic Assessment |
|
| Spinal cord infarction | Nervous system disorders | MedDRA Ver.16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Ver.16.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA Ver.16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Ver.16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Ver.16.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA Ver.16.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Ver.16.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA Ver.16.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA Ver.16.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA Ver.16.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA Ver.16.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA Ver.16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Ver.16.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Ver.16.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Ver.16.0 | Systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D007945 | Leukemia, Lymphoid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |