OncoMatch/Clinical Trials/NCT06906562
A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations
Is NCT06906562 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pemigatinib for advanced pancreatic carcinoma.
Treatment: Pemigatinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: FGFR2 fusion/translocation
Cohort 1: Pancreatic cancer of any histology with FGFR2 fusion/translocation
Required: FGFR1 activating point mutation
Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion/translocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications
Required: FGFR1 fusion/translocation
Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion/translocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications
Required: FGFR1 extracellular small indel
Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion/translocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications
Required: FGFR1 kinase domain duplication
Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion/translocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications
Required: FGFR3 activating point mutation
Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion/translocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications
Required: FGFR3 fusion/translocation
Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion/translocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications
Required: FGFR3 extracellular small indel
Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion/translocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications
Required: FGFR3 kinase domain duplication
Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion/translocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications
Required: FGFR4 activating point mutation
Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion/translocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications
Required: FGFR4 fusion/translocation
Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion/translocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications
Required: FGFR4 extracellular small indel
Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion/translocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications
Required: FGFR4 kinase domain duplication
Cohort 2: Pancreatic cancer of any histology with activating point mutations, fusion/translocation (FGFR1,3,4) extracellular small indels, or kinase domain duplications
Excluded: KRAS mutation
Patients with concurrent Kirsten rat sarcoma (KRAS) mutations are excluded from this cohort
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard of care therapy — advanced/metastatic pancreas cancer
Patients must have progressed on or are intolerant to at least one SOC therapy
Cannot have received: FGFR inhibitor
Prior therapy with a different FGFR inhibitor is not permitted. Patients who have received prior treatment with an alternate FGFR inhibitor are not eligible for the study
Cannot have received: cyclical chemotherapy
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)
Cannot have received: biological therapy (bevacizumab)
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
Cannot have received: small molecule therapeutics
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
Cannot have received: investigational agents
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
Cannot have received: wide field radiotherapy (therapeutic radioisotopes such as strontium 89)
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
Lab requirements
Blood counts
ANC > 1,000/mm^3; platelets > 75,000/mm^3; hemoglobin > 9.0 g/dL
Kidney function
Calculated or measured creatinine clearance ≥ 40 mL/min
Liver function
Total bilirubin < 1.5x ULN unless associated with primary cancer/metastases; AST and ALT < 3x ULN unless associated with primary cancer/metastases; alkaline phosphatase < 2.5x ULN unless associated with primary cancer/metastases
Cardiac function
No clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction, NYHA Class III or IV congestive heart failure, or arrhythmia requiring therapy. Subjects with a pacemaker and well-controlled rhythm for at least 1 month prior to first dose will be allowed
ANC ≤ 1,000/mm^3; Platelets ≤ 75,000/mm^3; Hemoglobin ≤ 9.0 g/dL; Total bilirubin ≥ 1.5x ULN unless associated with patient's primary cancer and/or metastases and with principal investigator's approval; AST and 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; History of clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure, or arrhythmia requiring therapy. Subjects with a pacemaker and well-controlled rhythm for at least 1 month prior to first dose will be allowed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University-Telemedicine · Birmingham, Alabama
- Ohio State University-Telemedicine · Mobile, Alabama
- Ohio State University Telemedicine · Montgomery, Alabama
- Ohio State University-Telemedicine · Anchorage, Alaska
- Ohio State University Telemedicine · Flagstaff, Arizona
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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