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Trial Title:
A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
NCT ID:
NCT05567185
Condition:
Urinary Bladder Neoplasms
Receptors, Fibroblast Growth Factor
Conditions: Official terms:
Urinary Bladder Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Erdafitinib Intravesical Delivery System
Description:
Erdafitinib intravesical delivery system will be administered.
Arm group label:
Dose Escalation: Erdafinitib Intravesical Delivery System
Other name:
JNJ-42756493
Summary:
The purpose of the study is to determine the tolerability of erdafitinib intravesical
delivery system (TAR-210) in Japanese participants.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed non-muscle-invasive urothelial carcinoma of the bladder
- 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:
- Histologically confirmed muscle-invasive (T2 or higher stage) urothelial carcinoma
of the bladder.
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St Marianna University Hospital
Address:
City:
Kanagawa
Zip:
216 8511
Country:
Japan
Status:
Recruiting
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka City
Zip:
541 8567
Country:
Japan
Status:
Recruiting
Facility:
Name:
Toyama University Hospital
Address:
City:
Toyama-shi
Zip:
930-0194
Country:
Japan
Status:
Recruiting
Facility:
Name:
University of Tsukuba Hospital
Address:
City:
Tsukuba
Zip:
305 8576
Country:
Japan
Status:
Recruiting
Start date:
March 3, 2023
Completion date:
September 24, 2027
Lead sponsor:
Agency:
Janssen Pharmaceutical K.K.
Agency class:
Industry
Source:
Janssen Pharmaceutical K.K.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05567185
