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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142429 | Other Identifier | Japan Pharmaceutical Information Center |
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| Name | Class |
|---|---|
| Korea Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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To compare disease-free survival in patients 60 years or older with acute myeloid leukemia (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCV-501 arm | Experimental |
| |
| Placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCV-501 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival | Disease-free survival (DFS) was defined as the time from randomization until relapse or death from any cause, whichever came first, by the DFS-cutoff date. | 2 years (treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Subjects were surveyed for survival by the date of cutoff. The cutoff date was set as the date after 728 days (2 years) from the day that the last subject started IMP administration. | 2 years (treatment period) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun-ichi Hashimoto, PhD | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
Of the 134 subjects randomized in this trial, one subject who was randomized but did not receive the investigational medicinal product (IMP) was excluded from all analysis data sets.
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| ID | Title | Description |
|---|---|---|
| FG000 | OCV-501 | 3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2015 | Feb 10, 2021 |
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|
| Chugoku Region |
| Japan |
| Hokkaido Region | Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Shikoku Region | Japan |
| Tohoku Region | Japan |
| Daegu | South Korea |
| Seoul | South Korea |
| Kaoshiung | Taiwan |
| Taichung | Taiwan |
| Tainan | Taiwan |
| Taipei | Taiwan |
Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward.
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS): all subjects who received the IMP at least once and from whom data on at least 1 efficacy endpoint were obtained after the start of IMP administration.
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| ID | Title | Description |
|---|---|---|
| BG000 | OCV-501 | 3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward. |
| BG001 | Placebo | Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Disease-Free Survival | Disease-free survival (DFS) was defined as the time from randomization until relapse or death from any cause, whichever came first, by the DFS-cutoff date. | FAS: all subjects who received the IMP at least once and from whom data on at least 1 efficacy endpoint were obtained after the start of IMP administration. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years (treatment period) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | Subjects were surveyed for survival by the date of cutoff. The cutoff date was set as the date after 728 days (2 years) from the day that the last subject started IMP administration. | FAS: all subjects who received the IMP at least once and from whom data on at least 1 efficacy endpoint were obtained after the start of IMP administration. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years (treatment period) |
|
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Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).
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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 | OCV-501 | 3 mg of OCV-501 (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward. | 1 | 68 | 7 | 68 | 67 | 68 |
| EG001 | Placebo | Placebo (0.4 mL) was administered subcutaneously, once-weekly up to the 8th administration, and once every 2 weeks from the 9th administration onward. | 1 | 65 | 7 | 65 | 59 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infectious colitis | Infections and infestations | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Stress cardiomyopathy | Cardiac disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Hepatitis acute | Hepatobiliary disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Hypoglycaemic encephalopathy | Nervous system disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site induration | General disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Injection site swelling | General disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Headache | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 9, 2018 | Feb 10, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| >=65 years |
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| Male |
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| Japan |
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| Taiwan |
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