Pemigatinib for Colorectal Cancer

Recruiting at6 trial locations

Overseen by Kristen K Ciombor

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Academic and Community Cancer Research United

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Pemigatinib may stop the growth of tumor cells by blocking FGFR, which is needed for cell growth.

Research Team

Kristen K Ciombor

Principal Investigator

Academic and Community Cancer Research United

Eligibility Criteria

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.

Inclusion Criteria

Patient must have received and progressed on, or be intolerant to, each of the following treatments for mCRC (or have contraindication to these treatments): Fluoropyrimidine, Oxaliplatin, Irinotecan, Anti-VEGF (vascular endothelial growth factor) monoclonal antibody, if eligible for this therapy, Anti-EGFR (epidermal growth factor receptor) monoclonal antibody, if eligible for this therapy, Measurable disease, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2, Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 28 days prior to registration), Platelet count >= 100,000/mm^3 (obtained =< 28 days prior to registration), Hemoglobin >= 9.0 g/dL (obtained =< 28 days prior to registration), Total bilirubin =< 1.5x upper limit of normal (ULN), or =< 2.5x ULN if patient has Gilbert syndrome or disease involving the liver (obtained =< 28 days prior to registration), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5x ULN (or =< 5x ULN in presence of suspected liver metastases) (obtained =< 28 days prior to registration), Serum phosphate < institutional ULN (obtained =< 28 days prior to registration), Serum calcium within institutional normal range, or serum albumin-corrected calcium within institutional normal range (if serum albumin is outside of the institutional normal range) (obtained =< 28 days prior to registration), Potassium levels > institutional lower limit of normal (supplementation can be used to correct potassium level during screening) (obtained =< 28 days prior to registration), Serum creatinine =< 1.5x ULN, or calculated creatinine clearance > 30 mL/min using the Cockcroft-Gault formula or 24-hours urine collection analysis (obtained =< 28 days prior to registration), Corrected QT interval (QTc) by Fridericia's method (QTcF) assessed by electrocardiogram (ECG) completed =< 28 days prior to registration, and resulted as: QTcF =< 450 msec in men, or QTcF =< 470 msec in women, Negative serum pregnancy test completed =< 7 days prior to registration, for women of childbearing potential only, Willing to provide tissue and blood samples for correlative research purposes, Willing to allow transfer of tissue and blood samples, clinical information, and outcome data collected from this trial for future research

My cancer has a specific genetic change in the FGFR1-3 genes.

Registered to Colorectal and Liquid Biopsy Molecularly Assigned Therapy (COLOMATE) Academic and Community Cancer Research United (ACCRU)-GI-1611 and COLOMATE Companion Trial Recommendation Form indicates patient qualifies to be screened for a COLOMATE companion trial

Exclusion Criteria

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

Treatment Details

Interventions

• Pemigatinib (Tyrosine Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Treatment (pemigatinib) Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Academic and Community Cancer Research United

Lead Sponsor

Trials

54

Recruited

4,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School