A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations

  • STATUS
    Recruiting
  • sponsor
    Incyte Corporation
Updated on 8 December 2020
Meir Medical Center (0.0 mi away) Contact
+61 other location
urinary tract cancer

Summary

A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations

Description

The purpose of this study is to evaluate the overall response rate (ORR) of INCB054828 as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.

For more information, please contact Incyte Corporation at 1.855.463.3463

Details
Condition Urothelial Tract Cancer
Clinical Study IdentifierTX152594
SponsorIncyte Corporation
Last Modified on8 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from ureters, upper tract, renal pelvis, and bladder
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Life expectancy = 12 weeks
Radiographically measurable or evaluable disease per RECIST v1.1
Known FGF/FGFR alteration and have either (a) failed at least 1 previous treatment (ie, chemotherapy, immunotherapy) or (b) have not received chemotherapy due to insufficient renal function or poor ECOG performance for their metastatic or surgically unresectable urothelial carcinoma

Exclusion Criteria

Prior receipt of a selective FGFR inhibitor
Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is shorter) before the first dose of study drug
Inability or unwillingness to swallow INCB054828 or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of INCB054828
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note