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Pemigatinib for Brain Tumor (FIGHT-209 Trial)
FIGHT-209 Trial Summary
This trial is testing a drug called pemigatinib for people with recurrent glioblastoma or other primary brain tumors. Pemigatinib will be given daily on a 2-week on, 1-week off schedule. The trial will enroll about 82 people in each of 3 cohorts.
FIGHT-209 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFIGHT-209 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 147 Patients • NCT02924376FIGHT-209 Trial Design
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- I have a specific type of brain tumor that has not responded to at least one standard treatment.My brain tumor has returned or worsened after treatment.My cancer has a specific FGFR gene change that can be targeted by treatment.My brain tumor has been confirmed through testing.I am taking more than 4 mg of dexamethasone daily.I have previously been treated with an FGFR inhibitor.My cancer has spread to the lining of my brain and spinal cord.I received radiation therapy less than 12 weeks ago.I can provide a tumor block or at least 15 slides from my cancer biopsy.I haven't taken bevacizumab or similar drugs for my cancer, except possibly for radiation necrosis.I haven't taken any cancer drugs or experimental medications in the last 28 days.I have another cancer that is getting worse or needs treatment.I can care for myself but may need occasional help.My MRI shows my condition worsened after treatment and no other treatments are likely to help.I am eligible for surgery that could potentially cure my condition.I am not currently receiving any cancer treatments.My brain tumor has come back and is confirmed by tests.My cancer can be seen and measured on scans.I can care for myself but may not be able to do active work.You are expected to live for at least 12 more weeks.
- Group 1: Cohort B: Other gliomas other than GBM
- Group 2: Cohort A: IDH-wild-type GBM
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this research initiative actively seeking participants?
"Affirmative. The clinicaltrials.gov website showcases that this research endeavour, which was first posted on May 20th 2022, is presently recruiting. A total of 189 participants need to be recruited from 40 trial sites."
How many participants is the clinical trial accepting at this time?
"Affirmative. Clinicaltrials.gov has confirmed that the recruitment phase for this trial is currently in effect; it was first posted on May 20th 2022 and most recently updated on November 15th 2022. This study requires 189 participants to be sourced from 40 different healthcare facilities."
Are the requirements for this trial compatible with my profile?
"This experimental trial is enrolling 189 participants with glioblastoma whose age falls between 18 and 99. Essential criteria that applicants must meet are as follows: (1) previously histologically verified WHO grade 4 IDH-wild-type GBM or molecularly diagnosed diffuse astrocytic glioma presenting features of WHO grade 4 GBM; (2) recurrent adult type diffuse gliomas, including pilocytic astrocytomas, bearing an FGFR 1 - 3 mutation; (3) radiographically identifiable disease progression; (4) Karnofsky rating ≥ 60%; (5) life expectancy > 12 weeks"
Does the eligibility criteria of this medical experiment include participants under the age of twenty?
"The eligibility requirements for this investigation specify that the youngest participant must be at least 18 years old, whereas the oldest individual can be no more than 99."
To what extent is this study accessible across multiple sites?
"This clinical trial has 40 recruiting sites, including Texas Oncology-Baylor Charles A. Sammons in Dallas, University Medical Center New Orleans in New Orleans and Rush University Medical Center - Consultants in Hematology in Chicago. There are also other locations where enrollment is taking place."
What outcomes is this research endeavor attempting to realize?
"The study sponsor, Incyte Corporation aims to quantify the Cohort B Objective Response Rate (ORR) over a 3-month period. Secondary outcomes evaluated in this trial include Disease Control Rate (DCR), overall response rate for cohorts A,B and C combined, as well as Overall Survival (OS)."
What risks, if any, are associated with the administration of Pemigatinib?
"Pemigatinib's safety is estimated to be a score of 2, as the drug has only gone through Phase 2 trials and there are limited data points confirming its efficacy."
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