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| Name | Class |
|---|---|
| Seagen Inc. | INDUSTRY |
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The objective of this study is to assess the safety, tolerability and pharmacokinetics of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma. This study will also assess the immunogenicity as defined by the incidence of anti-drug antibody (ADA) and anti-tumor activity of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma.
All subjects will receive a single 30 minute intravenous (IV) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Enfortumab vedotin 1.0 mg/kg | Experimental | 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. |
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| Arm B: Enfortumab vedotin 1.25 mg/kg | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enfortumab vedotin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by incidence of adverse events | Adverse events will be coded using MedDRA. Adverse events collection begins after signing informed consent and collected until 28 days after the last dose of study drug. | Up to 12 months |
| Safety assessed by laboratory tests: Hematology | Descriptive statistics will be used to summarize results. | Up to 12 months |
| Safety assessed by laboratory tests: Biochemistry | Descriptive statistics will be used to summarize results. | Up to 12 months |
| Safety assessed by laboratory tests: Urinalysis | Descriptive statistics will be used to summarize results. | Up to 12 months |
| Safety assessed by laboratory tests: Coagulation studies | Descriptive statistics will be used to summarize results. | Up to 12 months |
| Number of participants with vital sign abnormalities and/or adverse events | Number of participants with potentially clinically significant vital sign values. | Up to 12 months |
| Safety assessed by electrocardiogram (ECG) | Before measurement of ECGs, the participant should be resting in a supine position for at least 5 minutes. The investigator will assess the ECG charts as "normal", "abnormal (not clinically significant)" or "abnormal (clinically significant)". "Abnormal (not clinically significant)" and "abnormal (clinically significant)" findings will be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Anti-Drug Antibody (ADA) | Blood samples for anti-drug antibody (ADA) analysis will be collected. | Up to 12 months |
| Overall Response Rate | Defined as the proportion of subjects whose best overall response is rated as complete response (CR) or partial response (PR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site JP00003 | Tsukuba | Ibaraki | Japan | |||
| Site JP00005 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31444589 | Derived | 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. |
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000632577 | enfortumab vedotin |
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| Up to 12 months |
| Pharmacokinetics (PK) parameter for total antibody (TAb): Concentration at the end of infusion (CEOI) | CEOI will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| Pharmacokinetics (PK) parameter for antibody drug conjugate (ADC): CEOI | CEOI will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| Pharmacokinetics (PK) parameter for Monomethyl Auristatin E (MMAE): CEOI | CEOI will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for TAb: Maximum observed concentration (Cmax) | Cmax will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for ADC: Cmax | Cmax will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for MMAE: Cmax | Cmax will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for TAb: Trough concentration (Ctrough) | Ctrough will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for ADC: Ctrough | Ctrough will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for MMAE: Ctrough | Ctrough will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for TAb: Time to maximum concentration (Tmax) | Tmax will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for ADC: Tmax | Tmax will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for MMAE: Tmax | Tmax will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for TAb: Partial area under the serum concentration-time curve after first dose and as appropriate (AUC0-7) | AUC0-7 will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for ADC: AUC0-7 | AUC0-7 will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for MMAE: AUC0-7 | AUC0-7 will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for TAb: Terminal or apparent terminal half-life (t1/2) | T1/2 will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for ADC: t1/2 | T1/2 will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| PK parameter for MMAE: t1/2 | T1/2 will be derived from the PK blood samples collected. | Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months |
| Up to 12 months |
| Disease Control Rate | Defined as the proportion of subjects whose best overall response is rated as CR, PR, or stable disease (SD) | Up to 12 months |
| 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 |