A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations

Recruiting now · Phase 2

Conditions studied: Advanced Pancreatic Carcinoma, Metastatic Pancreatic Carcinoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8

In brief

This phase II study evaluates how well pemigatinib works for the treatment of adult patients with pancreatic cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has spread from where it first started to other places in the body (metastatic) and that have abnormal changes (alterations) in the fibroblast growth factor receptor (FGFR) gene. FGFR genes are genes that, when altered, can lead to and promote the growth of cancer in patients. Researchers want to test if using pemigatinib can block the function of these abnormal FGFR genes and prevent the tumor from growing and whether treatment can help improve overall quality of life.

Key facts

Study ID

NCT06906562

Run by

Sameek Roychowdhury

People needed

40

Starts

2025-08-26

Expected to finish

2028-12-31

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically or cytologically confirmed advanced or metastatic pancreatic cancer of any histologic classification at the time of diagnosis
• Written documentation of local or central Clinical Laboratory Improvement Act (CLIA)-certified laboratory determination of FGFR gene fusions/translocations or activating mutations
• The study is open to pancreatic cancer in the following cohorts:
• Cohort 1: Pancreatic cancer of any histology with FGFR2 fusion/translocation (n, up to 30) who have progressed on or are intolerant to at least one standard of care (SOC) therapy. Prior therapy with a different FGFR inhibitor is not permitted. Patients with concurrent Kirsten rat sarcoma (KRAS) mutations are excluded from this cohort
• Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion/translocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications (n, up to 10). Patients must have progressed on or are intolerant to at least one SOC therapy. Prior therapy with a different FGFR inhibitor is not permitted. Patients with concurrent KRAS mutations are permitted in this cohort
• Evidence of measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Patients must have received at least one prior SOC regimen for advanced/metastatic pancreas cancer. Patients should have had evidence of progressive disease following their prior regimen, or if prior treatment was discontinued due to toxicity must have continued evidence of measurable or evaluable disease. Patients who have received prior treatment with an alternate FGFR inhibitor are not eligible for the study
• Patients with symptomatic central nervous system (CNS) metastases are excluded (because it is unclear how much CNS penetration the drug has). However, asymptomatic patients with history of successfully treated CNS metastases with surgery or radiation and follow up imaging showing stability, can be eligible
• Patients ≥ 18 years of age of either gender
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (patients with ECOG performance status of 2 may be considered on a case-by-case basis after discussion with Incyte)
• Able to read and/or understand the details of the study and provide written evidence of informed consent as approved by Institutional Review Board (IRB)/Ethics Committee (EC)
• Recovery from adverse events of previous systemic anti-cancer therapies to baseline or Grade 1, except for:
• Alopecia
• Stable neuropathy of ≤ Grade 2 due to prior cancer therapy
• Able to swallow and retain oral medication
• Willing and able to comply with scheduled visits, treatment plan and laboratory tests

You may not qualify if…

• Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids.
• Note: Steroid use for management of CNS tumors is allowed but must be at a stable dose for at least 2 weeks preceding study entry
• History of another primary malignancy except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the course of the study or affect survival
• Any other medical condition that would, in the investigator's , prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
• Current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjuctivitis, confirmed by ophthalmologic examination
• History and/or current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral pemigatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
• Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc.
• Treatment with any of the following anti-cancer therapies prior to the first dose of pemigatinib within the stated timeframes:
• Cyclical chemotherapy (intravenous) within a period of time that is shorter than the cycle length used for that treatment (e.g., 6 weeks for nitrosourea, mitomycin-C)
• Biological therapy (e.g., antibodies - including bevacizumab) within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks, whichever is shorter, prior to starting study drug
• Continuous or intermittent small molecule therapeutics within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug
• Any other investigational agents within a period of time that is ≤ 5 t1/2 or less than the cycle length used for that treatment or ≤ 4 weeks (whichever is shortest) prior to starting study drug
• Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug
• Patients who are currently receiving treatment with agents that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration are excluded. Patients are not permitted to receive enzyme-inducing anti-epileptic drugs
• Consumption of grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star fruits, pomelos, Seville oranges or products within 7 days prior to first dose
• Absolute neutrophil count (ANC) ≤ 1,000/mm\^3 [1.0 x 10\^9/L]
• Platelets ≤ 75,000/mm\^3 [75 x 10\^9/L] • Hemoglobin ≤ 9.0 g/dL
• Total bilirubin ≥ 1.5x upper limit of normal (ULN) unless associated with patient's primary cancer and/or metastases and with principal investigator's approval
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 3x ULN unless associated with patient's primary cancer and/or metastases and with principal investigator's approval
• Alkaline phosphatase ≥ 2.5x ULN unless associated with patient's primary cancer and/or metastases and with principal investigator's approval
• Calculated or measured creatinine clearance of < 40 mL/min
• Calcium-phosphate homeostasis:
• Inorganic phosphorus outside of institutional normal limits
• Total serum calcium (can be corrected) outside of institutional normal limits

Where it is running

• Ohio State University-Telemedicine — Mobile, Alabama, United States (enrolling)
• Ohio State University Telemedicine — Montgomery, Alabama, United States (enrolling)
• Ohio State University-Telemedicine — Anchorage, Alaska, United States (enrolling)
• Ohio State University Telemedicine — Flagstaff, Arizona, United States (enrolling)
• Ohio State University-Telemedicine — Phoenix, Arizona, United States (enrolling)
• Ohio State University-Telemedicine — Tucson, Arizona, United States (enrolling)
• Ohio State University-Telemedicine — Hot Springs, Arkansas, United States (enrolling)
• Ohio State University Telemedicine — Fresno, California, United States (enrolling)
• Ohio State University-Telemedicine — Los Angeles, California, United States (enrolling)
• Ohio State University-Telemedicine — San Diego, California, United States (enrolling)
• Ohio State University-Telemedicine — San Francisco, California, United States (enrolling)
• Ohio State University-Telemedicine — Aurora, Colorado, United States (enrolling)
• Ohio State University Telemedicine — Denver, Colorado, United States (enrolling)
• Ohio State University Telemedicine — Durango, Colorado, United States (enrolling)
• Ohio State University Telemedicine — Grand Junction, Colorado, United States (enrolling)
• Ohio State University-Telemedicine — New Haven, Connecticut, United States (enrolling)
• Ohio State University-Telemedicine — Wilmington, Delaware, United States (enrolling)
• Ohio State University-Telemedicine — Washington D.C., District of Columbia, United States (enrolling)
• Ohio State University-Telemedicine — Jacksonville, Florida, United States (enrolling)
• Ohio State University-Telemedicine — Miami, Florida, United States (enrolling)
• Ohio State University-Telemedicine — Orlando, Florida, United States (enrolling)
• Ohio State University Telemedicine — Tallahassee, Florida, United States (enrolling)
• Ohio State University-Telemedicine — Tampa, Florida, United States (enrolling)
• Ohio State University-Telemedicine — Atlanta, Georgia, United States (enrolling)
• Ohio State University-Telemedicine — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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