A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer (TAR-210)
Primary Purpose
Urinary Bladder Neoplasms, Receptors, Fibroblast Growth Factor
Status
Recruiting
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Erdafitinib Intravesical Delivery System
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder Neoplasms
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
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to (<=) 2
- 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:
- 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
- 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)
Sites / Locations
- St.Marianna University HospitalRecruiting
- Osaka International Cancer InstituteRecruiting
- Toyama University HospitalRecruiting
- University of Tsukuba HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose Escalation: Erdafinitib Intravesical Delivery System
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Plasma Concentration of Erdafitinib
Plasma concentration of erdafitinib will be reported.
Urine Concentration of Erdafitinib
Urine concentration of erdafitinib will be reported.
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.
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.
Full Information
NCT ID
NCT05567185
First Posted
October 3, 2022
Last Updated
September 12, 2023
Sponsor
Janssen Pharmaceutical K.K.
1. Study Identification
Unique Protocol Identification Number
NCT05567185
Brief Title
A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
Acronym
TAR-210
Official Title
A Phase 1 Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of TAR-210 in Japanese Participants With Bladder Cancer and Selected FGFR Mutations or Fusions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2023 (Actual)
Primary Completion Date
October 16, 2026 (Anticipated)
Study Completion Date
October 16, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms, Receptors, Fibroblast Growth Factor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation: Erdafinitib Intravesical Delivery System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Erdafitinib Intravesical Delivery System
Other Intervention Name(s)
JNJ-42756493
Intervention Description
Erdafitinib intravesical delivery system will be administered.
Primary Outcome Measure Information:
Title
Number of Participants with Dose-limiting Toxicity (DLT)
Description
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.
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Plasma Concentration of Erdafitinib
Description
Plasma concentration of erdafitinib will be reported.
Time Frame
Up to 180 days
Title
Urine Concentration of Erdafitinib
Description
Urine concentration of erdafitinib will be reported.
Time Frame
Up to 180 days
Title
Number of Participants with Adverse Events (AEs)
Description
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.
Time Frame
Up to 3 years 10 months
Title
Number of Participants with AEs by Severity
Description
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.
Time Frame
Up to 3 years 10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
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:
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
Facility Name
St.Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toyama University Hospital
City
Toyama-shi
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Tsukuba Hospital
City
Tsukuba
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
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