A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
NCT ID: NCT05567185
Last Updated: 2025-12-11
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
5 participants
INTERVENTIONAL
2023-03-03
2027-09-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation: Erdafinitib Intravesical Delivery System
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.
Erdafitinib Intravesical Delivery System
Erdafitinib intravesical delivery system will be administered.
Interventions
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Erdafitinib Intravesical Delivery System
Erdafitinib intravesical delivery system will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All visible tumors must be completely resected prior to the start of study treatment and documented on screening cystoscopy
* Confirmed recurrence of non-muscle invasive bladder cancer (NMIBC) after prior therapy that meet either one: a. Recurrence of high-risk NMIBC (high-grade Ta or any-grade T1) within 12 months after adequate Bacillus Calmette-Guerin (BCG), or any-grade T1 within 3 months after 1st induction course, refusing or ineligible for radical cystectomy (RC). b. Recurrence of intermediate- or high-risk NMIBC (any-grade Ta/T1) after prior BCG regardless of the timing of recurrence, refusing or ineligible for RC and considering no other effective treatment options. c. Recurrence of intermediate-risk NMIBC (low grade Ta) after intravesical chemotherapy including maintenance therapy following a single dose after operation, no other effective intravesical chemotherapy is available and refusing BCG treatment
* At least 1 of the study protocol defined activating fibroblast growth factor receptors (FGFR) mutation or fusion, as determined by local or central testing using either tumor tissue or urine sample collected prior to trans urethral resection of bladder tumour (TURBT)
* Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to (\<=) 2
Exclusion Criteria
* Prior treatment with an fibroblast growth factor receptor (FGFR) inhibitor
* 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
* Participants with active bladder stones or history of bladder stones less than \[\< 6\] months prior to the start of study treatment
* Participants have concurrent or second malignancy other than the disease which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s); -Bladder post-void residual volume (PVR) \>350 mL after second voided urine, -Current central serous retinopathy or retinal pigment epithelial detachment of any-grade
18 Years
ALL
No
Sponsors
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Janssen Pharmaceutical K.K.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutical K.K., Japan Clinical Trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutical K.K.
Locations
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St Marianna University Hospital
Kanagawa, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Toyama University Hospital
Toyama, , Japan
University of Tsukuba Hospital
Tsukuba, , Japan
Countries
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Other Identifiers
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42756493BLC1004
Identifier Type: OTHER
Identifier Source: secondary_id
CR109248
Identifier Type: -
Identifier Source: org_study_id
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