Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer
NCT ID: NCT02792842
Last Updated: 2024-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
79 participants
INTERVENTIONAL
2016-07-31
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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
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
Placebo
Placebo
Placebo infusion once daily on days 1-3 in each cycle
Interventions
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ART-123 (3-day ART)
ART-123 380 U/kg infusion once daily on days 1-3 in each cycle
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
Placebo
Placebo infusion once daily on days 1-3 in each cycle
Eligibility Criteria
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Inclusion Criteria
* Deemed to have undergone curative A (Cur A) surgery
* Planning to undergo postoperative adjuvant chemotherapy
Exclusion Criteria
* Have any treatment history of systemic chemotherapy (including any drug in the clinical trial stage) or radiotherapy
* With active double cancer
20 Years
79 Years
ALL
No
Sponsors
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Asahi Kasei Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Asahi Kasei Pharma Corporation
Role: STUDY_CHAIR
Asahi Kasei Pharma Corporation
Locations
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Kobe, Hyōgo, Japan
Nerima City, Tokyo, Japan
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ART-123-201
Identifier Type: -
Identifier Source: org_study_id
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