A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations
2 other identifiers
interventional
40
1 country
109
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2025
Typical duration for phase_2
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2025
CompletedFirst Posted
Study publicly available on registry
April 2, 2025
CompletedStudy Start
First participant enrolled
August 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 17, 2026
February 1, 2026
1.3 years
March 26, 2025
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Up to 24 months
Secondary Outcomes (5)
Progression Free Survival (PFS)
Up to 12 months
Disease Control Rate (DCR)
Up to 12 months
Overall Survival (OS)
Up to 12 months
Type, frequency and severity of adverse events
Up to 12 months
Best overall response (BOR)
Baseline up to 1 year after completion of study treatment.
Study Arms (1)
Pemigatinib Treament
EXPERIMENTALPatients receive pemigatinib PO QD on days 1-14 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, CT and/or MRI, and OCT throughout the study. Patients may also undergo whole body bone scans and dilated fundoscopy as clinically indicated.
Interventions
Pemigatinib will be taken orally with a targeted starting does of 13.5 mg
Undergo CT scan
Undergo MRI
Undergo dilated ophthalmoscopy
Eligibility Criteria
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
- +1 more criteria
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
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sameek Roychowdhurylead
- Incyte Corporationcollaborator
Study Sites (109)
Ohio State University-Telemedicine
Birmingham, Alabama, 35205, United States
Ohio State University-Telemedicine
Mobile, Alabama, 36604, United States
Ohio State University Telemedicine
Montgomery, Alabama, 36104, United States
Ohio State University-Telemedicine
Anchorage, Alaska, 99508, United States
Ohio State University Telemedicine
Flagstaff, Arizona, 86001, United States
Ohio State University-Telemedicine
Phoenix, Arizona, 85054, United States
Ohio State University-Telemedicine
Tucson, Arizona, 85719, United States
Ohio State University-Telemedicine
Hot Springs, Arkansas, 71913, United States
Ohio State University Telemedicine
Fresno, California, 87901, United States
Ohio State University-Telemedicine
Los Angeles, California, 91010, United States
Ohio State University-Telemedicine
San Diego, California, 92037, United States
Ohio State University-Telemedicine
San Francisco, California, 94143, United States
Ohio State University-Telemedicine
Aurora, Colorado, 80045, United States
Ohio State University Telemedicine
Denver, Colorado, 80202, United States
Ohio State University Telemedicine
Durango, Colorado, 81301, United States
Ohio State University Telemedicine
Grand Junction, Colorado, 81501, United States
Ohio State University-Telemedicine
New Haven, Connecticut, 06510, United States
Ohio State University-Telemedicine
Wilmington, Delaware, 19713, United States
Ohio State University-Telemedicine
Washington D.C., District of Columbia, 20007, United States
Ohio State University-Telemedicine
Jacksonville, Florida, 32207, United States
Ohio State University-Telemedicine
Miami, Florida, 33136, United States
Ohio State University-Telemedicine
Orlando, Florida, 32806, United States
Ohio State University Telemedicine
Tallahassee, Florida, 32301, United States
Ohio State University-Telemedicine
Tampa, Florida, 33612, United States
Ohio State University-Telemedicine
Atlanta, Georgia, 30322, United States
Ohio State University-Telemedicine
Augusta, Georgia, 30912, United States
Ohio State University-Telemedicine
Honolulu, Hawaii, 96813, United States
Ohio State University-Telemedicine
Boise, Idaho, 83706, United States
Ohio State University Telemedicine
Lewiston, Idaho, 83501, United States
Ohio State University-Telemedicine
Champaign, Illinois, 61801, United States
Ohio State University-Telemedicine
Chicago, Illinois, 60637, United States
Ohio State University Telemedicine
Quincy, Illinois, 62301, United States
Ohio State University Telemedicine
Evansville, Indiana, 44708, United States
Ohio State University-Telemedicine
Fort Wayne, Indiana, 46804, United States
Ohio State University-Telemedicine
Indianapolis, Indiana, 46202, United States
Ohio State University-Telemedicine
Des Moines, Iowa, 50314, United States
Ohio State University-Telemedicine
Iowa City, Iowa, 52242, United States
Ohio State University Telemedicine
Colby, Kansas, 67701, United States
Ohio State University-Telemedicine
Kansas City, Kansas, 66160, United States
Ohio State University-Telemedicine
Wichita, Kansas, 67206, United States
Ohio State University-Telemedicine
Lexington, Kentucky, 40536, United States
Ohio State University Telemedicine
Lake Charles, Louisiana, 70601, United States
Ohio State University-Telemedicine
New Orleans, Louisiana, 70112, United States
Ohio State University Telemedicine
Shreveport, Louisiana, 77101, United States
Ohio State University-Telemedicine
Bar Harbor, Maine, 04609, United States
Ohio State University-Telemedicine
Baltimore, Maryland, 21231, United States
Ohio State University-Telemedicine
Boston, Massachusetts, 02215, United States
Ohio State University-Telemedicine
Ann Arbor, Michigan, 48109, United States
Ohio State University-Telemedicine
Detroit, Michigan, 48201, United States
Ohio State University-Telemedicine
Minneapolis, Minnesota, 55455, United States
Ohio State University Telemedicine
Rochester, Minnesota, 55901, United States
Ohio State University Telemedicine
Jackson, Mississippi, 39201, United States
Ohio State University Telemedicine
Springfield, Missouri, 65801, United States
Ohio State University-Telemedicine
St Louis, Missouri, 63110, United States
Ohio State University-Telemedicine
Bozeman, Montana, 59715, United States
Ohio State University Telemedicine
Miles City, Montana, 59301, United States
Ohio State University Telemedicine
North Platte, Nebraska, 69101, United States
Ohio State University-Telemedicine
Omaha, Nebraska, 68105, United States
Ohio State University-Telemedicine
Las Vegas, Nevada, 89166, United States
Ohio State University Telemedicine
Reno, Nevada, 89501, United States
Ohio State University-Telemedicine
Concord, New Hampshire, 03301, United States
Ohio State University-Telemedicine
Albuquerque, New Mexico, 87102, United States
Ohio State University Telemedicine
Roswell, New Mexico, 88201, United States
Ohio State University-Telemedicine
Albany, New York, 12208, United States
Ohio State University Telemedicine
Buffalo, New York, 14021, United States
Ohio State University-Telemedicine
New York, New York, 10065, United States
Ohio State University-Telemedicine
Syracuse, New York, 13210, United States
Ohio State University-Telemedicine
Charlotte, North Carolina, 28204, United States
Ohio State University-Telemedicine
Raleigh, North Carolina, 27614, United States
Ohio State University-Telemedicine
Bismarck, North Dakota, 58701, United States
Ohio State University-Telemedicine
Fargo, North Dakota, 58103, United States
Ohio State University-Telemedicine
Cincinnati, Ohio, 45219, United States
Ohio State University-Telemedicine
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Ohio State University-Telemedicine
Oklahoma City, Oklahoma, 73104, United States
Ohio State University Telemedicine
Eugene, Oregon, 97401, United States
Ohio State University-Telemedicine
Portland, Oregon, 97239, United States
Ohio State University-Telemedicine
Philadelphia, Pennsylvania, 48109, United States
Ohio State University-Telemedicine
Pittsburgh, Pennsylvania, 15232, United States
Ohio State University
Wellsboro, Pennsylvania, 16901, United States
Ohio State University-Telemedicine
Charleston, South Carolina, 29425, United States
Ohio State University Telemedicine
Rapid City, South Dakota, 57701, United States
Ohio State University Telemedicine
Sioux Falls, South Dakota, 57101, United States
Ohio State University Telemedicine
Knoxville, Tennessee, 37901, United States
Ohio State University-Telemedicine
Memphis, Tennessee, 38119, United States
Ohio State University-Telemedicine
Nashville, Tennessee, 37232, United States
Ohio State University Telemedicine
Amarillo, Texas, 79101, United States
Ohio State University-Telemedicine
Austin, Texas, 78745, United States
Ohio State University-Telemedicine
Dallas, Texas, 75208, United States
Ohio State University Telemedicine
Fort Stockton, Texas, 79735, United States
Ohio State University-Telemedicine
Houston, Texas, 77030, United States
Ohio State University Telemedicine
Midland, Texas, 79706, United States
Ohio State University-Telemedicine
San Antonio, Texas, 78229, United States
Ohio State University Telemedicine
Cedar City, Utah, 84720, United States
Ohio State University-Telemedicine
Salt Lake City, Utah, 84112, United States
Ohio State University-Telemedicine
Burlington, Vermont, 05401, United States
Ohio State University-Telemedicine
Norfolk, Virginia, 02301, United States
Ohio State University-Telemedicine
Richmond, Virginia, 23298, United States
Ohio State University Telemedicine
Roanoke, Virginia, 24011, United States
Ohio State University-Telemedicine
Seattle, Washington, 98109, United States
Ohio State University Telemedicine
Spokane, Washington, 99201, United States
Ohio State University Telemedicine
Huntington, West Virginia, 25701, United States
Ohio State University-Telemedicine
Morgantown, West Virginia, 26506, United States
Ohio State University Telemedicine
Chippewa Falls, Wisconsin, 54729, United States
Ohio State University Telemedicine
Green Bay, Wisconsin, 54301, United States
Ohio State University Telemedicine
Madison, Wisconsin, 53701, United States
Ohio State University-Telemedicine
Milwaukee, Wisconsin, 53226, United States
Ohio State University Telemedicine
Cheyenne, Wyoming, 82001, United States
Ohio State University Telemedicine
Jackson, Wyoming, 83003, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sameek Roychowdhury, MD, PhD
Ohio State University Comprehensive Cancer Center
Central Study Contacts
The Ohio State University Comprehensive Cancer Center and James Cancer Hospital
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 26, 2025
First Posted
April 2, 2025
Study Start
August 26, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
February 17, 2026
Record last verified: 2026-02