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The objective of the study is to investigate the pharmacokinetics of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-4538 1mg/kg | Experimental | ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, single dose |
|
| ONO-4538 3mg/kg | Experimental | ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, single dose |
|
| ONO-4538 10mg/kg | Experimental | ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4538 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK Outcome: Cmax of ONO-4538 | Cmax was the maximum serum concentration of ONO-4538 after the single administration. | 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr. |
| PK Outcome: Tmax of ONO-4538 | Tmax was the time to reach the Cmax. | 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr. |
| AUC21day | AUC21day was the area under serum concentration-time curve of ONO-4538 from day 0 to day 21 (last measurement). | 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr. |
| AUCinf | AUCinf was the area under serum concentration-time curve of ONO-4538 extrapolated to infinity. | 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr. |
| T1/2 | T1/2 was the elimination half-life of serum concentration of ONO-4538. | 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome: The Number of Subjects With Overall Adverse Events | Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following exposure to investigational product. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitsunobu Tanimoto | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seongnam-si Clinical Site 105 | Seongnam-si | Gyeonggi-do | South Korea | |||
| Seoul Clinical Site 101 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29158363 | Derived | Lee KW, Lee DH, Kang JH, Park JO, Kim SH, Hong YS, Kim ST, Oh DY, Bang YJ. Phase I Pharmacokinetic Study of Nivolumab in Korean Patients with Advanced Solid Tumors. Oncologist. 2018 Feb;23(2):155-e17. doi: 10.1634/theoncologist.2017-0528. Epub 2017 Nov 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ONO-4538 1 mg/kg | Subjects with advanced or recurrent solid tumors, received single dose of Nivolumab (ONO-4538) at a dose of 1 mg/kg as an intravenous infusion over approximately 60 minutes. |
| FG001 | ONO-4538 3 mg/kg | Subjects with advanced or recurrent solid tumors, received single dose of Nivolumab (ONO-4538) at a dose of 3 mg/kg as an intravenous infusion over approximately 60 minutes. |
| FG002 | ONO-4538 10 mg/kg | Subjects with advanced or recurrent solid tumors, received single dose of Nivolumab (ONO-4538) at a dose of 10 mg/kg as an intravenous infusion over approximately 60 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ONO-4538 1 mg/kg | Refer to "Participant Flow ". |
| BG001 | ONO-4538 3 mg/kg | Refer to "Participant Flow ". |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | PK Outcome: Cmax of ONO-4538 | Cmax was the maximum serum concentration of ONO-4538 after the single administration. | Posted | Mean | Standard Deviation | µg/mL | 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr. |
|
3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
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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 | ONO-4538 1 mg/kg | Refer to "Participant Flow ". | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood bilirubin increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Center | Ono Pharmaceutical Co., Ltd. | clinical_trial@ono-pharma.com |
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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 | Jan 8, 2015 | Sep 1, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2015 | Mar 21, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Increase the dose sequentially.
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| 3 weeks: from the start of administration to the end of treatment phase. |
| Safety Outcome: The Number of Deaths | Number of subjects with TEAEs leading to death. | 3 weeks: from the start of administration to the end of treatment phase. |
| Seoul |
| South Korea |
| Seoul Clinical Site 102 | Seoul | South Korea |
| Seoul Clinical Site 103 | Seoul | South Korea |
| Seoul Clinical Site 104 | Seoul | South Korea |
| BG002 |
| ONO-4538 10 mg/kg |
Refer to "Participant Flow ". |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Median | Full Range | Centimeter |
|
| Weight | Median | Full Range | Kilogram |
|
| BMI | Median | Full Range | Kilogram per square meter |
|
| Performance status (Eastern Cooperative Oncology Group) | PS 0 means "fully active, able to carry on all pre-disease performance without restriction" whereas PS 1 means "restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work". Please use the Measure Description to specify how participants were "staged" or "graded" clinically (e.g., briefly describe the criteria for the Rows or Categories) and specify which "stages" or "grades" were considered better or worse outcomes. | Count of Participants | Participants |
|
| Type of primary cancer | Count of Participants | Participants |
|
| History of surgery | Count of Participants | Participants |
|
| History of radiotherapy | Count of Participants | Participants |
|
| History of chemotherapy | Count of Participants | Participants |
|
Refer to "Participant Flow ".
|
|
| Primary | PK Outcome: Tmax of ONO-4538 | Tmax was the time to reach the Cmax. | Posted | Median | Full Range | hours | 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr. |
|
|
|
| Primary | AUC21day | AUC21day was the area under serum concentration-time curve of ONO-4538 from day 0 to day 21 (last measurement). | Posted | Mean | Standard Deviation | µg*h/mL | 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr. |
|
|
|
| Primary | AUCinf | AUCinf was the area under serum concentration-time curve of ONO-4538 extrapolated to infinity. | Posted | Mean | Standard Deviation | µg*h/mL | 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr. |
|
|
|
| Primary | T1/2 | T1/2 was the elimination half-life of serum concentration of ONO-4538. | Posted | Mean | Standard Deviation | days | 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr. |
|
|
|
| Secondary | Safety Outcome: The Number of Subjects With Overall Adverse Events | Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following exposure to investigational product. | Safety Analysis Set | Posted | Number | participants | 3 weeks: from the start of administration to the end of treatment phase. |
|
|
|
| Secondary | Safety Outcome: The Number of Deaths | Number of subjects with TEAEs leading to death. | Safety Analysis Set | Posted | Count of Participants | Participants | 3 weeks: from the start of administration to the end of treatment phase. |
|
|
|
| 6 |
| 1 |
| 6 |
| 5 |
| 6 |
| EG001 | ONO-4538 3 mg/kg | Refer to "Participant Flow ". | 0 | 6 | 0 | 6 | 4 | 6 |
| EG002 | ONO-4538 10 mg/kg | Refer to "Participant Flow ". | 1 | 6 | 1 | 6 | 5 | 6 |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Autoimmune thyroiditis | Endocrine disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Ulcerative keratitis | Eye disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Haemoglobinuria | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this tiral prior to submission for publication/presentation.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |