A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors
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- STATUS
- Recruiting
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- End date
- May 28, 2024
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- participants needed
- 43
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- sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
This phase II trial studies how well Pemigatinib (an orally administered inhibitor of fibroblast growth factor receptors 1, 2, and 3) works in non-muscle invasive bladder cancer (NMIBC) patients with recurrent tumors and a prior history of low- or intermediate-risk NMIBC tumors. Participants will receive pemigatinib for 4-6 weeks prior to standard of care transurethral resection of bladder tumor (TURBT).
Description
It is a single-arm phase 2 window of opportunity study to assess the antineoplastic activity of pemigatinib in non-muscle invasive bladder cancer (NMIBC) patients with recurrent tumors and a prior history of low- or intermediate-risk NMIBC tumors. Enrolled patients will receive pemigatinib for 4-6 weeks prior to standard of care transurethral resection of bladder tumor (TURBT). The primary endpoint will be complete response rate as determined at TURBT. Secondary endpoints will include safety profile, associations between complete response rate and tumor mutation/fusion status (e.g. FGFR3 specifically, others will also be examined) and NMIBC risk group (low- vs. intermediate-risk), and assessment of pemigatinib post-treatment urothelial tissue concentrations. The study will be conducted at 4-5 high volume bladder cancer institutions within the US and managed through the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center clinical research office.
Details
| Condition | Bladder Cancer, NMIBC, Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma Recurrent |
|---|---|
| Treatment | pemigatinib |
| Clinical Study Identifier | NCT03914794 |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Last Modified on | 19 February 2022 |
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