TAR-210: A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
Study Details
Study Description
Brief Summary
The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose Escalation: Erdafinitib Intravesical Delivery System Participants with bladder cancer and fibroblast growth factor receptor (FGFR) mutations or fusions will receive 2 dose levels of erdafitinib intravesical delivery system. 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. |
Drug: Erdafitinib Intravesical Delivery System
Erdafitinib intravesical delivery system will be administered.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with Dose-limiting Toxicity (DLT) [Up to 28 days]
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.
Secondary Outcome Measures
- Plasma Concentration of Erdafitinib [Up to 180 days]
Plasma concentration of erdafitinib will be reported.
- Urine Concentration of Erdafitinib [Up to 180 days]
Urine concentration of erdafitinib will be reported.
- Number of Participants with Adverse Events (AEs) [Up to 3 years 10 months]
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.
- Number of Participants with AEs by Severity [Up to 3 years 10 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed non-muscle-invasive urothelial carcinoma of the bladder
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All visible tumors must be completely resected prior to the start of study treatment and documented on screening cystoscopy
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At least 1 of the study protocol defined activating tumor fibroblast growth factor receptors (FGFR) mutation or fusion, as determined by local or central testing
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Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to (<=) 2
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A female participant of childbearing potential must have a negative serum test at screening and a negative urine test (or serum test if required by local regulations) within 72 hours of the first dose (that is, first insertion) of study treatment, and must agree to further serum or urine pregnancy tests during the study
Exclusion Criteria:
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Histologically confirmed muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder.
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Prior treatment with an fibroblast growth factor receptor (FGFR) inhibitor
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Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use, or removal of erdafitinib intravesical delivery system
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Participants with active bladder stones or history of bladder stones less than [< 6] months prior to the start of study treatment
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Toxicity from prior anticancer therapy has not resolved to baseline levels or to grade less than or equal to [<=] 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be grade 2)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St.Marianna University Hospital | Kanagawa | Japan | 216-8511 | |
| 2 | Osaka International Cancer Institute | Osaka | Japan | 541-8567 | |
| 3 | Toyama University Hospital | Toyama-shi | Japan | 930-0194 | |
| 4 | University of Tsukuba Hospital | Tsukuba | Japan | 305-8576 |
Sponsors and Collaborators
- Janssen Pharmaceutical K.K.
Investigators
- Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial, Janssen Pharmaceutical K.K.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109248
- 42756493BLC1004