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.
Written documentation of local or central Clinical Laboratory Improvement Act (CLIA)-certified laboratory determination of FGFR gene fusions/translocations or activating mutations
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
Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids.
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
Single group
Pemigatinib
DrugPemigatinib will be taken orally with a targeted starting does of 13.5 mg
Computed Tomography (CT)
Procedure/SurgeryUndergo CT scan
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Optical Coherence Tomography
Procedure/SurgeryUndergo OCT
Bone Scan
Procedure/SurgeryUndergo whole body bone scan
Ophthalmoscopy
Procedure/SurgeryUndergo dilated ophthalmoscopy
Overall Response Rate (ORR)
The proportion of patients with a best overall response of complete response (CR) or partial response (PR). Overall response rate assessed per RECIST v1.1. Will be evaluated in all patients who received at least 80% of the recommended dose of pemigatinib averaged over a 9-week period. ORR will be calculated along with its 95% confidence interval
Progression Free Survival (PFS)
PFS will be evaluated in all patients who received at least 80% of the recommended dose of pemigatinib averaged over a 9-week period. Will be analyzed using the Kaplan-Meier method.
Disease Control Rate (DCR)
Defined as the proportion of patients with a best overall response of CR or PR or SD. Will be assessed using descriptive stats. The estimated ORR and corresponding 95% confidence intervals based on the binomial distribution will be reported.
Overall Survival (OS)
OS will be evaluated in all patients who received at least 80% of the recommended dose of pemigatinib averaged over a 9-week period. Will be analyzed using the Kaplan-Meier method.
Type, frequency and severity of adverse events
The severity of AEs will be assessed according to the NCI CTCAE v5.0
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Sameek Roychowdhury
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Incyte Corporation
Collaborator
