A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors
|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: NCT03914794|
Recruitment Status : Not yet recruiting
First Posted : April 15, 2019
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer NMIBC Non-Muscle Invasive Bladder Cancer Urothelial Carcinoma Recurrent||Drug: Pemigatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Window of Opportunity Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2023|
Experimental: Treatment: Pemigatinib
Patients will receive pemigatinib for 4 to 6 weeks prior to standard of care transurethral resection of bladder tumor (TURBT).
Participants will take Pemigatinib once daily on days 1 through 28 of each cycle prior to standard of care TURBT.
- Complete response rate of pemigatinib therapy [ Time Frame: 6 weeks ]The number of participants with a complete response to pemigatinib therapy. Tumor complete response is defined as the complete absence of any stage bladder tumor on post-treatment Transurethral Resection of a Bladder Tumor (TURBT) and no evidence of recurrent urothelial carcinoma on post-treatment urine cytology.
- Characterize the safety profile of pemigatinib therapy [ Time Frame: 4 years ]Number of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 toxicities
- Number of Participants with Complete Response and FGFR3 Mutational Status [ Time Frame: Up to 4 weeks ]
- Number of Participants with Non-Muscle Invasive Bladder Cancer (NMIBC) and Complete Response [ Time Frame: Up to 4 years ]Number of participants with complete response rate and baseline NMIBC risk group (low- vs. intermediate-risk)
- Maximal concentration (Cmax, nmol/L) of pemigatinib in urothelial tissue at post-treatment TURBT [ Time Frame: Up to 4 weeks ]
- Relapse Free Survival (RFS) at 6 months [ Time Frame: 6 months ]Number of months from achieving a complete response at initial post-treatment TURBT until relapse.
- Relapse Free Survival (RFS) at 12 months [ Time Frame: 12 months ]Number of months from achieving a complete response at initial post-treatment TURBT until relapse.
- Relapse Free Survival (RFS) at 24 months [ Time Frame: 24 months ]Number of months from achieving a complete response at initial post-treatment TURBT until relapse.
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): NCT03914794
|Contact: Abby Asiamaemail@example.com|
|Contact: Rana Sullivanfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center||Not yet recruiting|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Noah M Hahn, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|