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Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Primary Purpose

Urinary Bladder Neoplasms, Receptors, Fibroblast Growth Factor

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Erdafitinib Intravesical Delivery System
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Neoplasms focused on measuring Non-Muscle-Invasive Bladder Cancer (NIMBC), Muscle-Invasive Bladder Cancer (MIBC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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

Sites / Locations

  • University of Southern CaliforniaRecruiting
  • H. Lee Moffitt Cancer CenterRecruiting
  • Northwestern UniversityRecruiting
  • Levine Cancer Institute, Carolinas HealthCare SystemRecruiting
  • Carolina Urologic Research CenterRecruiting
  • Urology AssociatesRecruiting
  • Urology San Antonio ResearchRecruiting
  • Universitatsklinikum FrankfurtRecruiting
  • Marien hospital HerneRecruiting
  • Universitätsklinikum MünsterRecruiting
  • Universitaetsklinikum UlmRecruiting
  • National Cancer CenterRecruiting
  • Chonnam National University HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • The Catholic University of Korea Seoul St. Mary's HospitalRecruiting
  • Radboud Umcn
  • UMC Utrecht
  • Fundacion PuigvertRecruiting
  • Hosp. Univ. Vall D HebronRecruiting
  • Hosp. Clinic I Provincial de BarcelonaRecruiting
  • Hosp. Univ. 12 de OctubreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1: Dose Escalation

Part 2: Dose Expansion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 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.
Number of Participants with Dose-limiting Toxicity (DLT)
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

Plasma Concentration of Erdafitinib
Plasma concentration of Erdafitinib will be reported.
Urine Concentration of Erdafitinib
Urine concentration of Erdafitinib will be reported.
Cohorts 1 and 2: Recurrence-Free Survival (RFS)
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.
Cohort 3 and 5: Complete Response (CR) Rate
CR is defined as the absence of urothelial carcinoma by cystoscopy, confirmed pathologically at first assessment, and negative urine cytology.
Cohort 3 and 5: Duration of CR
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.
Cohort 4: Pathological Complete Response (pCR) Rate
pCR rate is defined as percentage of participants with no pathologic evidence of intravesical disease (pT0) and no pathologic evidence of nodal involvement (pN0).
Cohort 4: No Pathologic Evidence of Intravesical Disease (pT0)
pT0 rate is defined as percentage of participants with no Pathologic Evidence of Intravesical Disease.
Cohort 4: Rate of downstaging to Less than (<) pT2
Rate of downstaging to <pT2 is defined as percentage of participants with pT stage <2.

Full Information

First Posted
March 30, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05316155
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2022 (Actual)
Primary Completion Date
April 11, 2025 (Anticipated)
Study Completion Date
April 14, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

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
Keywords
Non-Muscle-Invasive Bladder Cancer (NIMBC), Muscle-Invasive Bladder Cancer (MIBC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Dose Escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2: Dose Expansion
Arm Type
Experimental
Arm Description
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.
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 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 5 years 3 months
Title
Number of Participants with AEs by Severity
Description
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.
Time Frame
Up to 5 years 3 months
Title
Number of Participants with Dose-limiting Toxicity (DLT)
Description
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.
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
Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks
Title
Urine Concentration of Erdafitinib
Description
Urine concentration of Erdafitinib will be reported.
Time Frame
Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks
Title
Cohorts 1 and 2: Recurrence-Free Survival (RFS)
Description
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.
Time Frame
Up to 5 years 3 months
Title
Cohort 3 and 5: Complete Response (CR) Rate
Description
CR is defined as the absence of urothelial carcinoma by cystoscopy, confirmed pathologically at first assessment, and negative urine cytology.
Time Frame
At 3 months
Title
Cohort 3 and 5: Duration of CR
Description
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.
Time Frame
Up to 5 years 3 months
Title
Cohort 4: Pathological Complete Response (pCR) Rate
Description
pCR rate is defined as percentage of participants with no pathologic evidence of intravesical disease (pT0) and no pathologic evidence of nodal involvement (pN0).
Time Frame
Up to 8 weeks
Title
Cohort 4: No Pathologic Evidence of Intravesical Disease (pT0)
Description
pT0 rate is defined as percentage of participants with no Pathologic Evidence of Intravesical Disease.
Time Frame
Up to 8 weeks
Title
Cohort 4: Rate of downstaging to Less than (<) pT2
Description
Rate of downstaging to <pT2 is defined as percentage of participants with pT stage <2.
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recurrent, non-muscle-invasive or 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
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 Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Cancer Institute, Carolinas HealthCare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Name
Urology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Individual Site Status
Recruiting
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Marien hospital Herne
City
Herne
ZIP/Postal Code
44625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyang-Si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Radboud Umcn
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Completed
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Completed
Facility Name
Fundacion Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
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

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

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