History of Changes for Study: NCT05316155

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

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Study Record Versions

Version	Submitted Date	Changes
1	March 30, 2022	None (earliest Version on record)
2	April 21, 2022	Recruitment Status, Contacts/Locations, Study Status, Oversight and Study Identification
3	May 19, 2022	Study Status and Contacts/Locations
4	June 16, 2022	Study Status
5	July 14, 2022	Study Status and Contacts/Locations
6	August 11, 2022	Study Status
7	September 8, 2022	Study Status
8	October 21, 2022	Study Status, Contacts/Locations, Eligibility and Outcome Measures
9	November 3, 2022	Study Status
10	December 1, 2022	Contacts/Locations and Study Status
11	December 28, 2022	Contacts/Locations and Study Status
12	January 27, 2023	Contacts/Locations and Study Status
13	February 23, 2023	Study Status and Contacts/Locations
14	March 23, 2023	Contacts/Locations and Study Status
15	April 11, 2023	Study Status and Contacts/Locations
16	May 2, 2023	Study Status and Contacts/Locations
17	May 30, 2023	Contacts/Locations and Study Status
18	June 28, 2023	Study Status
19	July 19, 2023	Study Status
20	September 8, 2023	Contacts/Locations, Outcome Measures, Study Status, Eligibility, Arms and Interventions and Study Design
21	October 10, 2023	Study Status
22	November 7, 2023	Study Status and Contacts/Locations
23	December 5, 2023	Study Status and Study Design
24	January 2, 2024	Study Status
25	February 28, 2024	Arms and Interventions, Study Description, Study Status, IPDSharing, Eligibility and Study Design
26	March 26, 2024	Study Status and Contacts/Locations
27	April 23, 2024	Study Status and Contacts/Locations
28	May 21, 2024	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CR109115
Brief Title:	Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Official Title:	Phase 1 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non- Muscle-Invasive or Muscle-Invasive Bladder Cancer and Selected FGFR Mutations or Fusions
Secondary IDs:	42756493BLC1003 [Janssen Research & Development, LLC]

Study Status


Record Verification:	February 2022
Overall Status:	Not yet recruiting
Study Start:	March 28, 2022
Primary Completion:	April 11, 2025 [Anticipated]
Study Completion:	April 14, 2027 [Anticipated]

First Submitted:	March 30, 2022
First Submitted that Met QC Criteria:	March 30, 2022
First Posted:	April 7, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	March 30, 2022
Last Update Posted:	April 7, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Janssen Research & Development, LLC
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief Summary:

The purpose of the study in Part 1 (dose escalation) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and in Part 2 (dose expansion) is to determine the safety of Erdafitinib Intravesical Delivery System administered at the RP2D(s).

Detailed Description:

Bladder cancer is the most common malignancy worldwide where non-muscle invasive (NMIBC), requiring intensive regimens of frequent monitoring, local resection (transurethral resection of bladder [TURBT]). This study enrolls participants with non-muscle invasive or muscle invasive bladder cancer with activating fibroblast growth factor receptor (FGFR) mutations or fusions. Erdafitinib is a pan-FGFR inhibitor with demonstrated clinical activity when administered orally in patients with solid tumors, including bladder cancer, with FGFR genetic alterations. The Erdafitinib intravesical delivery system is designed to provide release of Erdafitinib in the bladder to treat localized bladder cancer, while reducing systemic toxicities. The study consists of a screening phase, a treatment phase, and a follow-up phase. Total duration of the study is 5 years 3 months.

Conditions


Conditions:	Urinary Bladder Neoplasms Receptors, Fibroblast Growth Factor
Keywords:	Non-Muscle-Invasive Bladder Cancer (NIMBC) Muscle-Invasive Bladder Cancer (MIBC)

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	92 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Experimental: Part 1: Dose Escalation

Participants with recurrent, bacillus Calmette-Guerin (BCG)-experienced high risk papillary-only Non-Muscle-Invasive Bladder Cancer (NMIBC), refusing or ineligible for radical cystectomy or with recurrent, intermediate-risk NMIBC will receive Erdafitinib Intravesical Delivery System. The dose will be escalated to determine preliminary recommended phase 2 dose(s) (RP2D[s]) for Part 2.

Drug: Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

Other Names:

JNJ-42756493

Experimental: Part 2: Dose Expansion

Participants in each of 4 disease-specific NMIBC or MIBC cohorts may be enrolled at one or more dose levels that have been determined to be safe in Part 1.

Drug: Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

Other Names:

JNJ-42756493

Outcome Measures


Primary Outcome Measures:
1.	Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 5 years 3 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.
2.	Number of Participants with AEs by Severity [ Time Frame: Up to 5 years 3 months ] Severity 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.
3.	Number of Participants with Dose-limiting Toxicity (DLT) [ Time Frame: Up to 28 days ] Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Secondary Outcome Measures:
1.	Plasma Concentration of Erdafitinib [ Time Frame: Cohorts 1 and 3: up to 6 months; Cohort 2 and 4: up to 8 weeks ] Plasma concentration of Erdafitinib will be reported.
2.	Urine Concentration of Erdafitinib [ Time Frame: Cohorts 1 and 3: up to 6 months; Cohort 2 and 4: up to 8 weeks ] Urine concentration of Erdafitinib will be reported.
3.	Cohorts 1 and 2: Recurrence-Free Survival (RFS) [ Time Frame: Up to 5 years 3 months ] RFS is defined as the time from start of treatment to the first detection of high-grade Ta or T1 bladder cancer or positive urine cytology.
4.	Cohort 3: Complete Response (CR) Rate [ Time Frame: Up to 5 years 3 months ] CR is defined as the absence of urothelial carcinoma by cystoscopy, confirmed pathologically at first assessment, and negative urine cytology.
5.	Cohort 3: Duration of CR [ Time Frame: Up to 5 years 3 months ] Duration of CR is defined as the time from first documentation of CR until the date of documented recurrence or progression, or death, whichever comes first.
6.	Cohort 4: Pathological Complete Response (pCR) Rate [ Time Frame: Up to 5 years 3 months ] pCR rate is defined as percentage of participants with no pathologic evidence of intravesical disease (pT0) and no pathologic evidence of nodal involvement (pN0).
7.	Cohort 4: No Pathologic Evidence of Intravesical Disease (pT0) [ Time Frame: Up to 5 years 3 months ] pT0 rate is defined as percentage of participants with no Pathologic Evidence of Intravesical Disease.
8.	Cohort 4: Rate of downstaging to Less than (<) pT2 [ Time Frame: Up to 5 years 3 months ] Rate of downstaging to <pT2 is defined as percentage of participants with pT stage <2.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Recurrent, non-muscle-invasive or muscle-invasive urothelial carcinoma of the Bladder Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment: Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC) Cohorts 2 and 4: Willing and eligible for RC Exclusion Criteria: Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor Received pelvic radiotherapy <=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system Indwelling urinary catheter. Intermittent catheterization is acceptable

Contacts/Locations


Central Contact Person:	Study Contact Telephone: 844-434-4210 Email: JNJ.CT@sylogent.com
Study Officials:	Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Locations:	United States, California
	University of Southern California Los Angeles, California, United States, 90033
	Cedars-Sinai Medical Center Los Angeles, California, United States, 90048
	United States, Colorado
	The Urology Center of Colorado Denver, Colorado, United States, 80211
	United States, Illinois
	Northwestern University Chicago, Illinois, United States, 60611
	United States, North Carolina
	Levine Cancer Institute, Carolinas HealthCare System Charlotte, North Carolina, United States, 28204
	United States, South Carolina
	Carolina Urologic Research Center Myrtle Beach, South Carolina, United States, 29572
	United States, Tennessee
	Urology Associates Nashville, Tennessee, United States, 37209
	United States, Texas
	Urology San Antonio Research San Antonio, Texas, United States, 78229
	France
	Hopital Edouard Herriot - CHU Lyon Lyon cedex 03, France, 69437
	Korea, Republic of
	National Cancer Center Goyang-Si, Korea, Republic of, 10408
	Chonnam National University Hospital Gwangju, Korea, Republic of, 61469
	The Catholic University of Korea, Seoul St. Mary's Hospital Seoul, Korea, Republic of, 06591
	Seoul National University Hospital Seoul, Korea, Republic of, 3080
	Spain
	Fundacion Puigvert Barcelona, Spain, 08025
	Hosp. Univ. Vall D Hebron Barcelona, Spain, 08035
	Hosp. Clinic I Provincial de Barcelona Barcelona, Spain, 08036
	Hosp. Univ. 12 de Octubre Madrid, Spain, 28041

IPDSharing


Plan to Share IPD:	Yes 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
	Supporting Information:
	Time Frame:
	Access Criteria:
	URL: https://www.janssen.com/clinical-trials/transparency

References


Citations:
Links:
Available IPD/Information: