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The purpose of this study is to evaluate the efficacy and safety of ART-123 for the prevention of cancer treatment related symptoms in patients with postoperative stage II / III colon cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ART-123 (3-day ART) | Experimental |
| |
| ART-123 (1-day ART) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ART-123 (3-day ART) | Drug | ART-123 380 U/kg infusion once daily on days 1-3 in each cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Cumulative Rates of Participants With NCI-CTCAE Grade 2 or Higher Peripheral Sensory Neuropathy: Up to End of Study Treatment | NCI-CTCAE was used for investigator-reported outcomes of peripheral sensory neuropathy; it was assessed every day from day 1 to day 3 of each cycle and on days 15 (the day after 14 days have elapsed from the date of administration) of Cycle 12 and 43 (the day after 42 days have elapsed from the date of administration of Cycle 12) of cycle 12 as follow-up assessment. Once grade 2 or higher neuropathy was observed in a certain participant, that participant was categorized as grade 2 or higher even if the grade returned to 1 or lower in subsequent cycles. Participants who discontinued the study or whose evaluation data were missing without reaching grade 2 or higher neuropathy were analyzed as no grade 2 or higher neuropathy. No primary endpoint was specified due to the exploratory nature of the study. | 42 days after the start of cycle 12 (each cycle is 2 weeks). |
| Least-squares (LS) Means of Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) Version 4.0 Score at Cycle 12 | Participant-reported outcomes were evaluated using the FACT/GOG-Ntx-12 version 4.0, which measured the severity and impact of symptoms of neuropathy over the past 7 days. Scores range from 0 to 48, with lower scores indicating more severe neurotoxicity. Participants completed paper questionnaires on days 1 and 8 of each cycle, on day 15 (the day after 14 days have elapsed from the date of administration) of cycle 12 and day 43 (the day after 42 days have elapsed from the date of administration) of cycle 12 as follow-up assessment. LS means were calculated from the mixed effect model for repeated measures (MMRM). Analysis included the fixed, categorical effects of study treatment, analysis visit, and study treatment-by-visit interaction. If multiple measurements occurred within the same visit, the measurement with the worst value was used. No primary endpoint was specified due to the exploratory nature of the study. | At baseline, at each cycle (up to cycle 12 with each cycle of 2 weeks), and follow-up assessment. |
| The Discontinuation Rate of Oxaliplatin Due to Oxaliplatin-Induced Peripheral Neuropathy (OIPN) |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asahi Kasei Pharma Corporation | Asahi Kasei Therapeutics Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe | Hyōgo | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32965539 | Derived | Kotaka M, Saito Y, Kato T, Satake H, Makiyama A, Tsuji Y, Shinozaki K, Fujiwara T, Mizushima T, Harihara Y, Nagata N, Kurihara N, Ando M, Kusakawa G, Sakai T, Uchida Y, Takamoto M, Kimoto S, Hyodo I. A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy. Cancer Chemother Pharmacol. 2020 Nov;86(5):607-618. doi: 10.1007/s00280-020-04135-8. Epub 2020 Sep 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ART-123 (3-day ART) | ART-123 (3-day ART): ART-123 380 U/kg infusion once daily on days 1-3 in each cycle |
| FG001 | ART-123 (1-day ART) | ART-123 (1-day ART): ART-123 380 U/kg infusion once on day 1 and placebo infusion once daily on days 2-3 in each cycle |
| 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 | Apr 22, 2016 | Apr 4, 2022 |
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| ART-123 (1-day ART) | Drug | ART-123 380 U/kg infusion once on day 1 and placebo infusion once daily on days 2-3 in each cycle |
|
| Placebo | Drug | Placebo infusion once daily on days 1-3 in each cycle |
|
The number of people who discontinued oxaliplatin because of OIPN was counted and the percentage of the total was calculated. No primary endpoint was specified due to the exploratory nature of the study.
| Cycle 12（each cycle is 2 weeks） |
| Nerima City |
| Tokyo |
| Japan |
| FG002 | Placebo | Placebo: Placebo infusion once daily on days 1-3 in each cycle |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomly assigned participants who received at least one dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | ART-123 (3-day ART) | ART-123 (3-day ART): ART-123 380 U/kg infusion once daily on days 1-3 in each cycle |
| BG001 | ART-123 (1-day ART) | ART-123 (1-day ART): ART-123 380 U/kg infusion once on day 1 and placebo infusion once daily on days 2-3 in each cycle |
| BG002 | Placebo | Placebo: Placebo infusion once daily on days 1-3 in each cycle |
| BG003 | 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 |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | The Cumulative Rates of Participants With NCI-CTCAE Grade 2 or Higher Peripheral Sensory Neuropathy: Up to End of Study Treatment | NCI-CTCAE was used for investigator-reported outcomes of peripheral sensory neuropathy; it was assessed every day from day 1 to day 3 of each cycle and on days 15 (the day after 14 days have elapsed from the date of administration) of Cycle 12 and 43 (the day after 42 days have elapsed from the date of administration of Cycle 12) of cycle 12 as follow-up assessment. Once grade 2 or higher neuropathy was observed in a certain participant, that participant was categorized as grade 2 or higher even if the grade returned to 1 or lower in subsequent cycles. Participants who discontinued the study or whose evaluation data were missing without reaching grade 2 or higher neuropathy were analyzed as no grade 2 or higher neuropathy. No primary endpoint was specified due to the exploratory nature of the study. | The preventive effect of ART-123 on neuropathy was analyzed in all randomly assigned participants who received at least one dose of study drug and oxaliplatin and had a FACT/GOG-Ntx-12 or NCI-CTCAE evaluation at least once after oxaliplatin administration. | Posted | Count of Participants | Participants | 42 days after the start of cycle 12 (each cycle is 2 weeks). |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Least-squares (LS) Means of Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) Version 4.0 Score at Cycle 12 | Participant-reported outcomes were evaluated using the FACT/GOG-Ntx-12 version 4.0, which measured the severity and impact of symptoms of neuropathy over the past 7 days. Scores range from 0 to 48, with lower scores indicating more severe neurotoxicity. Participants completed paper questionnaires on days 1 and 8 of each cycle, on day 15 (the day after 14 days have elapsed from the date of administration) of cycle 12 and day 43 (the day after 42 days have elapsed from the date of administration) of cycle 12 as follow-up assessment. LS means were calculated from the mixed effect model for repeated measures (MMRM). Analysis included the fixed, categorical effects of study treatment, analysis visit, and study treatment-by-visit interaction. If multiple measurements occurred within the same visit, the measurement with the worst value was used. No primary endpoint was specified due to the exploratory nature of the study. | The preventive effect of ART-123 on neuropathy was analyzed in all randomly assigned participants who received at least one dose of study drug and oxaliplatin and had a FACT/GOG-Ntx-12 or NCI-CTCAE evaluation at least once after oxaliplatin administration. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At baseline, at each cycle (up to cycle 12 with each cycle of 2 weeks), and follow-up assessment. |
| |||||||||||||||||||||||||||||||||
| Primary | The Discontinuation Rate of Oxaliplatin Due to Oxaliplatin-Induced Peripheral Neuropathy (OIPN) | The number of people who discontinued oxaliplatin because of OIPN was counted and the percentage of the total was calculated. No primary endpoint was specified due to the exploratory nature of the study. | The preventive effect of ART-123 on neuropathy was analyzed in all randomly assigned participants who received at least one dose of study drug and oxaliplatin and had a FACT/GOG-Ntx-12 or NCI-CTCAE evaluation at least once after oxaliplatin administration. | Posted | Count of Participants | Participants | Cycle 12（each cycle is 2 weeks） |
|
From informed consent until the day 42 days have elapsed from the Cycle 12, with each cycle of 2 weeks, administration date
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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 | ART-123 (3-day ART) | ART-123 (3-day ART): ART-123 380 U/kg infusion once daily on days 1-3 in each cycle | 0 | 24 | 3 | 24 | 24 | 24 |
| EG001 | ART-123 (1-day ART) | ART-123 (1-day ART): ART-123 380 U/kg infusion once on day 1 and placebo infusion once daily on days 2-3 in each cycle | 0 | 27 | 5 | 27 | 27 | 27 |
| EG002 | Placebo | Placebo: Placebo infusion once daily on days 1-3 in each cycle | 0 | 28 | 2 | 28 | 28 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infective spondylitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastrointestinal mucosal disorder | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Asahi Kasei Pharma Corporation | +81-3-6699-3600 | ct-info@om.asahi-kasei.co.jp |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2018 | May 17, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| C472045 | ART123 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| OG001 |
| ART-123 (1-day ART) |
ART-123 (1-day ART): ART-123 380 U/kg infusion once on day 1 and placebo infusion once daily on days 2-3 in each cycle |
| OG002 | Placebo | Placebo: Placebo infusion once daily on days 1-3 in each cycle |
|
|
| Units | Counts |
|---|
| Participants |
|
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