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Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

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ClinicalTrials.gov Identifier: NCT05316155
Recruitment Status : Recruiting
First Posted : April 7, 2022
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D.

Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasms Receptors, Fibroblast Growth Factor Drug: Erdafitinib Intravesical Delivery System Phase 1

Detailed Description:
Bladder cancer is one of the most common malignancy worldwide, and non-muscle invasive (NMIBC) requires intensive regimens of frequent monitoring and 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 11, 2022
Estimated Primary Completion Date : March 30, 2028
Estimated Study Completion Date : March 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Erdafitinib

Arms and Interventions
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Arm Intervention/treatment
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 Name: JNJ-42756493
Experimental: Part 2: Dose Expansion
Participants in each of 5 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 Name: JNJ-42756493
Experimental: Part 3: RP2D Dose Expansion
Participants in 2 of the disease-specific NMIBC cohorts (cohorts 1 and 3) may be enrolled at RP2D to determine the safety, evaluate PK and preliminary clinical activity.
 Drug: Erdafitinib Intravesical Delivery System
Erdafitinib intravesical delivery system will be administered.
Other Name: JNJ-42756493


Outcome Measures
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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, 3 and 5: 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, 3 and 5: 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 any new high-grade bladder cancer or upper tract urothelial carcinoma or positive urine cytology.

  4. Cohort 3 and 5: Complete Response (CR) Rate [ Time Frame: At 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 and 5: 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 8 weeks ]
    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 8 weeks ]
    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 8 weeks ]
    Rate of downstaging to <pT2 is defined as percentage of participants with pT stage <2.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder
  • For selected Cohorts: 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. Participants who received an abbreviated course of BCG due to toxicity are still eligible
  • 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 and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05316155


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05316155    
Other Study ID Numbers: CR109115
42756493BLC1003 ( Other Identifier: Janssen Research & Development, LLC )
2021-004144-22 ( EudraCT Number )
First Posted: April 7, 2022    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Non-Muscle-Invasive Bladder Cancer (NIMBC)
Muscle-Invasive Bladder Cancer (MIBC)
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases