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Tyrosine Kinase Inhibitor

Pemigatinib for Colorectal Cancer

Phase 2
Waitlist Available
Led By Kristen K Ciombor
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documentation of an activating genomic alteration(s) in FGFR1-3 (gain of function mutations, translocations, and amplifications allowed)
Histologically or cytologically confirmed diagnosis of metastatic or unresectable colorectal cancer (mCRC), based on documentation from local or outside review of pathology according to each site's established institutional procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 29.4 months
Awards & highlights

Study Summary

This trial studies pemigatinib for treating colorectal cancer with FGFR mutations that has spread or cannot be removed by surgery.

Who is the study for?
This trial is for adults with metastatic or unresectable colorectal cancer that has specific FGFR gene alterations. Participants must have tried and not responded to standard treatments, including chemotherapy and targeted therapies like anti-VEGF and anti-EGFR if applicable. They should be in a relatively stable condition (ECOG performance status of 0, 1, or 2) with adequate organ function and no significant heart issues, eye disorders, or other serious health problems.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Pemigatinib—a drug designed to block FGFR which tumors need to grow—in patients whose colorectal cancer has spread and cannot be surgically removed. It's a phase II study focusing on how well this treatment works when traditional options fail due to specific genetic changes in the tumor.See study design
What are the potential side effects?
Pemigatinib may cause side effects such as dry eyes or vision problems due to its effect on cell growth pathways. Other potential side effects include fatigue, digestive disturbances, liver enzyme changes, blood count variations, electrolyte imbalances, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has a specific genetic change in the FGFR1-3 genes.
Select...
My colorectal cancer is confirmed to be advanced and cannot be removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~29.4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 29.4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Clinical Benefit Rate
Incidence of Adverse Events
Overall Survival (OS)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pemigatinib)Experimental Treatment2 Interventions
Patients receive pemigatinib PO QD on days 1-21. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemigatinib
2022
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,139 Total Patients Enrolled
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,122 Total Patients Enrolled
Kristen K CiomborPrincipal InvestigatorAcademic and Community Cancer Research United
1 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

Pemigatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04096417 — Phase 2
Colorectal Cancer Research Study Groups: Treatment (pemigatinib)
Colorectal Cancer Clinical Trial 2023: Pemigatinib Highlights & Side Effects. Trial Name: NCT04096417 — Phase 2
Pemigatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04096417 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are participating in this clinical trial?

"This study is not looking for new enrollees at the moment. However, it's worth mentioning that this clinical trial was originally posted on 8/31/2020 and was most recently edited on 10/18/2022. If you are interested in other studies, there are 3351 trials actively recruiting participants with colorectal carcinoma and 13 trials for Pemigatinib that are currently enrolling patients."

Answered by AI

What is the unique selling point of this research?

"Pemigatinib has a long clinical history, with the first trials being conducted in 2017. These initial tests were sponsored by Incyte Corporation and involved 47 patients. Pemigatinib received Phase 2 drug approval after these successful early studies. At present, there are 13 active global trials involving this medication taking place across 41 countries and 98 cities."

Answered by AI

What are the possible side effects of Pemigatinib?

"Pemigatinib's current status as a Phase 2 drug means that while there is some evidence indicating it is safe, none of the clinical trials have yet yielded data supporting its efficacy."

Answered by AI

What other medical studies have there been surrounding Pemigatinib?

"Emory University - Winship Cancer Institute first studied pemigatinib in 2017 and, to date, there have been 126 completed trials. There are presently 13 actively recruiting studies, a significant number of which taking place in Atlanta, Georgia."

Answered by AI

Are there any availabilities for new patients in this clinical trial?

"The clinicaltrial.gov website indicates that this particular trial is not currently enrolling patients. Although, there are 3364 other trials that are still open for recruitment."

Answered by AI

Why is Pemigatinib prescribed to patients?

"Pemigatinib is a treatment for unresectable, metastatic cholangiocarcinomas that can not be surgically removed. This medication works by targeting the fgfr2 protein."

Answered by AI

Who else is applying?

What site did they apply to?
Emory University Hospital/Winship Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations
2020. "Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04096417.
All > Colorectal Cancer Glendale
~3 spots leftby Apr 2025
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