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FGFR tyrosine kinase inhibitors for the treatment of urothelial carcinoma

A technique for urothelial carcinoma, FGFR3Y373C, applied in the field of FGFR tyrosine kinase inhibitors for the treatment of urothelial carcinoma

Pending Publication Date: 2021-11-12
JANSSEN PHARMA NV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

To date, there are no approved therapies with FGFR inhibitors effective for patients with FGFR alterations

Method used

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  • FGFR tyrosine kinase inhibitors for the treatment of urothelial carcinoma
  • FGFR tyrosine kinase inhibitors for the treatment of urothelial carcinoma
  • FGFR tyrosine kinase inhibitors for the treatment of urothelial carcinoma

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0213] Example 1: Phase 2, multicenter, open-label study (NCT 02365597)

[0214] A phase 2, multicenter, open-label study was conducted to evaluate erdafitinib in subjects with metastatic or unresectable urothelial carcinoma carrying a selective FGFR genetic alteration (FGFR translocation or mutation) efficacy and safety.

[0215] The study included a screening phase (molecular screening at any time prior to the first dose and study screening within 30 days of the first dose), a treatment phase, and a post-treatment follow-up phase. The treatment period included the period from the first dose to the end-of-treatment follow-up. The follow-up period was extended until the subject died, withdrew consent, was lost to follow-up, or the end of the study, whichever came first.

[0216] Study treatments were administered in 28-day cycles. Prior to interim analysis 1, there were 2 treatment options. Patients were randomly assigned to the following 2 regimens in a 1:1 to 28-day cycl...

example 2

[0334] Example 2: Pharmacodynamics and Pharmacokinetics

[0335] Pharmacodynamics

[0336] Cardiac Electrophysiology

[0337] Erdafitinib had no major effect on the QTc interval (ie, >20 ms) based on the assessment of the QTc interval in an open-label, dose-escalation, and dose-expansion study in 187 patients with cancer.

[0338] serum phosphate

[0339] Erdafitinib increased serum phosphate levels due to FGFR inhibition. Erdafitinib should be increased to the maximum recommended dose early in the cycle and administered continuously daily to achieve a target serum phosphate level of 5.5-7.0 mg / dL

[0340] Drugs that increase serum phosphate levels (such as potassium phosphate supplements, vitamin D supplements, antacids, phosphate-containing enemas or laxatives, and drugs known to contain phosphate drug as an excipient), unless there is no substitute. To manage elevated phosphate, the use of phosphate binders is permitted. Avoid concomitant use of agents that alter ...

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Abstract

Described here are methods of treating urothelial carcinoma in a patient comprising evaluating a biological sample from the patient for the presence of at least two fibroblast growth factor receptor (FGFR) genetic alterations and treating the patient with an FGFR inhibitor. Also described herein are methods of treating urothelial carcinoma in a patient harboring at least two fibroblast growth factor receptor (FGFR) genetic alterations comprising administering a FGFR inhibitor.

Description

technical field [0001] Disclosed herein are methods of treating urothelial carcinoma in a patient, the methods comprising assessing the presence or absence of at least two fibroblast growth factor receptor (FGFR) genetic alterations in a biological sample from the patient, and if the at least two genetic alterations are present in the sample, Two fibroblast growth factor receptor (FGFR) genetic alterations, treat the patient with an FGFR inhibitor. Also disclosed herein are methods of treating urothelial carcinoma in patients carrying at least two fibroblast growth factor receptor (FGFR) genetic alterations comprising administering an FGFR inhibitor. Background technique [0002] Identification of genetic abnormalities may be useful in selecting one or more appropriate therapies for cancer patients. It is also useful for cancer patients who have failed the primary treatment option (first-line therapy), especially in the absence of an accepted standard of care for second or ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/498A61P35/00
CPCA61K31/498A61P35/00G01N33/574G01N2333/705C07K14/71C12Q1/6886C12Q2600/156C12Q2600/106
Inventor A·N·阿瓦达尼A·E·奥哈根A·E·圣地亚哥-沃克尔
Owner JANSSEN PHARMA NV
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