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| ID | Type | Description | Link |
|---|---|---|---|
| 42756493BLC1004 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation: Erdafinitib Intravesical Delivery System | Experimental | Participants with bladder cancer and fibroblast growth factor receptor (FGFR) mutations or fusions will receive erdafitinib intravesical delivery system and study will evaluate 2 dose levels of erdafitinib. Participants with a complete response (CR) may continue to receive treatment up to a duration of 1 year as long as there is no disease recurrence or progression, intolerable toxicity or withdrawal of consent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erdafitinib Intravesical Delivery System | Drug | Erdafitinib intravesical delivery system will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose-limiting Toxicity (DLT) | Number of participants with DLT will be assessed. The DLTs are specific adverse events related to erdafitinib intravesical delivery system and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Erdafitinib | Plasma concentration of erdafitinib will be reported. | Up to 180 days |
| Urine Concentration of Erdafitinib | Urine concentration of erdafitinib will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Marianna University Hospital | Kanagawa | 216 8511 | Japan | |||
| Osaka International Cancer Institute |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D000168 | Acrocephalosyndactylia |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000604580 | erdafitinib |
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|
| Up to 180 days |
| Number of Participants with Adverse Events (AEs) | An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to 3 years 10 months |
| Number of Participants with AEs by Severity | Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. | Up to 3 years 10 months |
| Osaka |
| 541 8567 |
| Japan |
| Toyama University Hospital | Toyama | 930-0194 | Japan |
| University of Tsukuba Hospital | Tsukuba | 305 8576 | Japan |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D003398 | Craniosynostoses |
| D013580 | Synostosis |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013576 | Syndactyly |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D017880 | Limb Deformities, Congenital |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |