Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05316155 |
Recruitment Status :
Recruiting
First Posted : April 7, 2022
Last Update Posted : April 24, 2024
|
Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | March 30, 2022 | ||||||
First Posted Date ICMJE | April 7, 2022 | ||||||
Last Update Posted Date | April 24, 2024 | ||||||
Actual Study Start Date ICMJE | April 11, 2022 | ||||||
Estimated Primary Completion Date | March 30, 2028 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
|
||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE |
|
||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer | ||||||
Official Title ICMJE | 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 | ||||||
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. | ||||||
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 Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
Condition ICMJE |
|
||||||
Intervention ICMJE | Drug: Erdafitinib Intravesical Delivery System
Erdafitinib intravesical delivery system will be administered.
Other Name: JNJ-42756493
|
||||||
Study Arms ICMJE |
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
112 | ||||||
Original Estimated Enrollment ICMJE |
92 | ||||||
Estimated Study Completion Date ICMJE | March 31, 2028 | ||||||
Estimated Primary Completion Date | March 30, 2028 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
|
||||||
Listed Location Countries ICMJE | Germany, Korea, Republic of, Netherlands, Spain, United States | ||||||
Removed Location Countries | France | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT05316155 | ||||||
Other Study ID Numbers ICMJE | CR109115 42756493BLC1003 ( Other Identifier: Janssen Research & Development, LLC ) 2021-004144-22 ( EudraCT Number ) |
||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement ICMJE |
|
||||||
Current Responsible Party | Janssen Research & Development, LLC | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Janssen Research & Development, LLC | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
|
||||||
PRS Account | Janssen Research & Development, LLC | ||||||
Verification Date | April 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |