Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement

  • STATUS
    Recruiting
  • participants needed
    54
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Send
Updated on 16 February 2024
See if I qualify
measurable disease
systemic therapy
cholangiocarcinoma
non-resectable cholangiocellular carcinoma
pemigatinib
FGFR2
non-resectable cholangiocarcinoma

Summary

This is a phase 2 study to investigate the efficacy and safety of Pemigatinib in treating patients with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 rearrangement who have failed at least 1 previous therapy

Details
Condition Adenocarcinoma, Adenocarcinoma, Cholangiocarcinoma
Age 18years - 100years
Treatment Pemigatinib
Clinical Study IdentifierNCT04256980
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Men and women, aged 18 or older
Histologically or cytologically confirmed cholangiocarcinoma which was considered to be advanced/metastatic or surgically unresectable by the investigator through image examination
Radiographically measurable disease per RECIST v 1.1
Documentation of FGFR2 rearrangement
Documented disease progression after at least 1 line of prior systemic therapy
ECOG performance status of 0~1
Life expectancy 12 weeks

Exclusion Criteria

Prior receipt of a selective FGFR inhibitor
History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of softy tissues ( exception: skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance)
Currently evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination
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. Topical ketoconazole will be allowed
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

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

Browse trials for

measurable disease
systemic therapy
cholangiocarcinoma
non-resectable cholangiocellular carcinoma
pemigatinib
FGFR2
non-resectable cholangiocarcinoma

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