Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

  • STATUS
    Recruiting
  • End date
    Jun 25, 2022
  • participants needed
    170
  • sponsor
    Incyte Corporation
Updated on 1 April 2021
Investigator
Incyte Corporation Call Center
Primary Contact
Institut Universitaire du Cancer de Toulouse Oncopole (0.5 mi away) Contact
+122 other location

Summary

The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations.

Details
Condition Solid Tumor Malignancy
Treatment pemigatinib
Clinical Study IdentifierNCT03822117
SponsorIncyte Corporation
Last Modified on1 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic or is surgically unresectable
Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measureable if progression has been clearly demonstrated in the lesion
Documentation of an FGFR1-3 gene mutation or translocation
Objective progression after at least 1 prior therapy and no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit
Eastern Cooperative Oncology Group performance status 0 to 2
Baseline archival tumor specimen (if less than 24 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

Prior receipt of a selective FGFR inhibitor in the past 6 months
Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib
Cannot be a candidate for potentially curative surgery
Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination
Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment
Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases)
Known additional malignancy that is progressing or requires active treatment
History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues
Clinically significant or uncontrolled cardiac disease
Active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed)
Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no cirrhosis and no elevated transaminases is allowed)
Known HIV infection
Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or five half-lives (whichever is longer) before the first dose of study drug/treatment
Women who are pregnant or breastfeeding
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

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...

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