A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
NCT ID: NCT03070990
Last Updated: 2024-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2017-04-24
2019-02-25
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
TREATMENT
NONE
Study Groups
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Arm A: Enfortumab vedotin 1.0 mg/kg
All subjects assigned will receive a single 30 minute intravenous infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days.
Enfortumab vedotin
All subjects assigned will receive a single 30 minute intravenous infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days.
Arm B: Enfortumab vedotin 1.25 mg/kg
All subjects assigned will receive a single 30 minute intravenous infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days.
Enfortumab vedotin
All subjects assigned will receive a single 30 minute intravenous infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days.
Interventions
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Enfortumab vedotin
All subjects assigned will receive a single 30 minute intravenous infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must be able to submit a tumor tissue samples for Nectin-4 expression analysis at central laboratory.
* Subject must have failed at least one prior chemotherapy regimen for advanced disease. Urothelial and bladder cancer subjects are not required to have failed prior chemotherapy regimen if considered unfit for cisplatin-based chemotherapy.
* Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumor (RECIST) (version 1.1).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria
* Preexisting motor neuropathy Grade ≥ 2.
* Uncontrolled central nervous system metastasis that requires active treatment.
* Any anticancer therapy within 14 days prior to the first dose of study drug.
* Subjects with pre-existing immunotherapy-related adverse events requiring high doses of systemic steroids are not eligible.
20 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Inc
Locations
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Site JP00003
Tsukuba, Ibaraki, Japan
Site JP00005
Sendai, Miyagi, Japan
Site JP00008
Suita, Osaka, Japan
Site JP00004
Chuo-ku, Tokyo, Japan
Site JP00007
Koto-ku, Tokyo, Japan
Site JP00006
Fukuoka, , Japan
Site JP00001
Niigata, , Japan
Site JP00002
Okayama, , Japan
Countries
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References
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Takahashi S, Uemura M, Kimura T, Kawasaki Y, Takamoto A, Yamaguchi A, Melhem-Bertrandt A, Gartner EM, Inoue T, Akazawa R, Kadokura T, Tanikawa T. A phase I study of enfortumab vedotin in Japanese patients with locally advanced or metastatic urothelial carcinoma. Invest New Drugs. 2020 Aug;38(4):1056-1066. doi: 10.1007/s10637-019-00844-x. Epub 2019 Aug 14.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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7465-CL-0101
Identifier Type: -
Identifier Source: org_study_id
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