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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

Must not have

Prior treatment with pemigatinib, Prior treatment with a selective FGFR inhibitor =< 180 days (6 months) prior to registration, Known hypersensitivity or severe reaction to an FGFR inhibitor, or to the excipients of pemigatinib (i.e. microcrystalline cellulose, sodium starch glycolate, and magnesium stearate), Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination, Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications =< 14 days prior to registration, Major surgery =< 28 days prior to registration, External beam radiation therapy =< 28 days prior to registration, or palliative radiation for non-central nervous system (CNS) disease =< 14 days prior to registration, Brain metastases, central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression, History or presence of significant cardiovascular disease or condition including: Uncontrolled angina pectoris (Canadian Cardiovascular Society grade II-IV despite medical therapy), Congestive heart failure (New York Heart Association class III or IV), Uncontrolled arrhythmia requiring therapy. Note: Patients with a pacemaker and well-controlled rhythm for >= 28 days prior to registration are not excluded, Any of the following occurring =< 6 months prior to registration: myocardial infarction, angioplasty, cardiac stenting, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, Failure to adequately recover (i.e. to =< grade 1 [according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5] or to pre-treatment baseline) from adverse events (AEs) deemed by the investigator as clinically significant and attributed to prior therapy. Exception: alopecia, Current use of prohibited medication, Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers =< 14 days or 5 half-lives (whichever is shorter) prior to registration. Note: topical ketoconazole will be allowed, History of hypovitaminosis D requiring supraphysiologic doses to replenish the deficiency. Note: patients receiving vitamin D food supplements are allowed, History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung; with the exception of calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification, Unable or unwilling to swallow pemigatinib and keep a medication diary, or significant gastrointestinal disorder(s) that could interfere with absorption, metabolism or excretion of pemigatinib per the discretion of the investigator, Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown: Pregnant women, Nursing women, Women of childbearing potential or men able to father children who have a female partner of childbearing potential, who are unwilling to employ acceptable contraception, Known history of human immunodeficiency (HIV) infection or positivity on immunoassay confirmed per local standards, Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Other known active malignancy =< 5 years prior to registration, EXCEPTIONS: Non-melanotic skin cancer or carcinoma in situ of the cervix, provided there is no known active disease and no additional therapy for the condition is ongoing or required during the trial period, NOTE: anti-estrogen/androgen therapy or bisphosphonates allowed, Co-morbid systemic illness, other severe concurrent disease, or psychiatric illness/social situation which, in the judgment of the investigator, would make the patient inappropriate for entry into this study, limit compliance with study requirements, or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 29.4 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 29.4 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR)

Secondary study objectives

Clinical Benefit Rate

Incidence of Adverse Events

Overall Survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~300

0 / 3Eligibility criteria met