Advanced Pancreatic CarcinomaPhase 2NCT06906562
A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations
A Phase 2 study testing Pemigatinib, Computed Tomography (CT) and Magnetic Resonance Imaging in people with Advanced Pancreatic Carcinoma and Metastatic Pancreatic Carcinoma, run by Sameek Roychowdhury at 109 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Carcinoma, Metastatic Pancreatic Carcinoma, Stage II Pancreatic Cancer AJCC v8
- What is being tested?
- Pemigatinib, Computed Tomography (CT) and Magnetic Resonance Imaging
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 109 sitesUnited States
- Study dates
- 26 Aug 2025to 31 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- 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
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months following the discontinuation of study treatment. Highly effective contraception methods include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment
- Male sterilization (at least 6 months prior to screening). For female patients on the study the vasectomized male partner should be the sole partner for that patient
- Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine systems (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential
- Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after the last dose of the study drug and should not father a child in this period. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the drug via seminal fluid
Trial locations and contacts
109 sites in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center and James Cancer Hospital contact
109 sites in 1 country
United States109 sites, 109 recruiting
- Recruiting
Ohio State University-Telemedicine
Albany, New York, 12208
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Albuquerque, New Mexico, 87102
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Amarillo, Texas, 79101
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Anchorage, Alaska, 99508
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Ann Arbor, Michigan, 48109
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Atlanta, Georgia, 30322
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Augusta, Georgia, 30912
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Aurora, Colorado, 80045
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Austin, Texas, 78745
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Baltimore, Maryland, 21231
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Bar Harbor, Maine, 04609
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Birmingham, Alabama, 35205
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Bismarck, North Dakota, 58701
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Boise, Idaho, 83706
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Boston, Massachusetts, 02215
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Bozeman, Montana, 59715
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Buffalo, New York, 14021
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Burlington, Vermont, 05401
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Cedar City, Utah, 84720
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Champaign, Illinois, 61801
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Charleston, South Carolina, 29425
Sameek Roychowdhur, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Charlotte, North Carolina, 28204
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Cheyenne, Wyoming, 82001
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Chicago, Illinois, 60637
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Chippewa Falls, Wisconsin, 54729
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Cincinnati, Ohio, 45219
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Cleveland, Ohio, 44195
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Colby, Kansas, 67701
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Sameek Roychowdhury, MD, PhD, 614-685-5842, Sameek.Roychowdhury@osumc.edu
Sameek Roychowdhury, MD, PhD
- Recruiting
Ohio State University-Telemedicine
Concord, New Hampshire, 03301
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Dallas, Texas, 75208
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Denver, Colorado, 80202
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Des Moines, Iowa, 50314
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Detroit, Michigan, 48201
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Durango, Colorado, 81301
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Eugene, Oregon, 97401
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Evansville, Indiana, 44708
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Fargo, North Dakota, 58103
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Flagstaff, Arizona, 86001
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Fort Stockton, Texas, 79735
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Fort Wayne, Indiana, 46804
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Fresno, California, 87901
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Grand Junction, Colorado, 81501
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Green Bay, Wisconsin, 54301
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Honolulu, Hawaii, 96813
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Hot Springs, Arkansas, 71913
Sameek Roychowdhury, MD, PhD, 734-474-8359, Sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Houston, Texas, 77030
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Huntington, West Virginia, 25701
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Indianapolis, Indiana, 46202
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Iowa City, Iowa, 52242
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Jackson, Mississippi, 39201
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Jackson, Wyoming, 83003
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Jacksonville, Florida, 32207
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Kansas City, Kansas, 66160
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Knoxville, Tennessee, 37901
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Lake Charles, Louisiana, 70601
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Las Vegas, Nevada, 89166
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Lewiston, Idaho, 83501
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Lexington, Kentucky, 40536
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Los Angeles, California, 91010
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Madison, Wisconsin, 53701
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Memphis, Tennessee, 38119
Sameek Roychowdhury, MD, Phd, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Miami, Florida, 33136
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Midland, Texas, 79706
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Miles City, Montana, 59301
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Milwaukee, Wisconsin, 53226
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Minneapolis, Minnesota, 55455
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Mobile, Alabama, 36604
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Montgomery, Alabama, 36104
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Morgantown, West Virginia, 26506
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Nashville, Tennessee, 37232
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
New Haven, Connecticut, 06510
Sameek Roychowdhury, MD, Phd, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
New Orleans, Louisiana, 70112
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
New York, New York, 10065
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Norfolk, Virginia, 02301
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
North Platte, Nebraska, 69101
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Oklahoma City, Oklahoma, 73104
Sameek Roychowdhury, MD, Phd, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Omaha, Nebraska, 68105
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Orlando, Florida, 32806
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Philadelphia, Pennsylvania, 48109
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Phoenix, Arizona, 85054
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Pittsburgh, Pennsylvania, 15232
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Portland, Oregon, 97239
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Quincy, Illinois, 62301
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Raleigh, North Carolina, 27614
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Rapid City, South Dakota, 57701
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Reno, Nevada, 89501
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Richmond, Virginia, 23298
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Roanoke, Virginia, 24011
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Rochester, Minnesota, 55901
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Roswell, New Mexico, 88201
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Salt Lake City, Utah, 84112
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
San Antonio, Texas, 78229
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
San Diego, California, 92037
Sameek Roychowdhury, MD, Phd, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
San Francisco, California, 94143
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Seattle, Washington, 98109
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Shreveport, Louisiana, 77101
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Sioux Falls, South Dakota, 57101
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Spokane, Washington, 99201
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Springfield, Missouri, 65801
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
St Louis, Missouri, 63110
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Syracuse, New York, 13210
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University Telemedicine
Tallahassee, Florida, 32301
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Tampa, Florida, 33612
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Tucson, Arizona, 85719
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Washington D.C., District of Columbia, 20007
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University
Wellsboro, Pennsylvania, 16901
Sameek Roychowdhury, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Wichita, Kansas, 67206
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
- Recruiting
Ohio State University-Telemedicine
Wilmington, Delaware, 19713
Sameek Roychowdhury, MD, PhD, 734-474-8359, sameek.roychowdhury@osumc.edu
About this study
Official title: A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR2 Gene Fusions or Other FGFR Genetic Alterations
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of single agent pemigatinib in patients with advanced or metastatic pancreas cancer of any histologic classification with FGFR2 gene fusions/translocations.
II. To understand response rate and potential for pemigatinib to benefit patients who have other FGFR alterations including point mutations, extracellular small indels and kinase domain duplications in pancreas cancer.
SECONDARY OBJECTIVES:
- To further evaluate the efficacy of single agent pemigatinib in each above cohort separately.
II. To characterize the safety and tolerability of single agent pemigatinib.
EXPLORATORY OBJECTIVE:
- To evaluate dynamics of cell-free deoxyribonucleic acid (DNA) (cfDNA) optimized for monitoring response to pemigatinib and detecting emerging resistance mutations to pemigatinib.
OUTLINE: Patients receive pemigatinib orally (PO) once daily (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, computed tomography (CT) and/or magnetic resonance imaging (MRI), and optical coherence tomography (OCT) throughout the study. Patients may also undergo whole body bone scans and dilated fundoscopy as clinically indicated. After completion of study treatment, patients are followed up at 30 days, then every 4 months for one year.
- Conditions
- Advanced Pancreatic Carcinoma, Metastatic Pancreatic Carcinoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8
- Being tested
- Pemigatinib, Computed Tomography (CT), Magnetic Resonance Imaging, Optical Coherence Tomography, Bone Scan
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Also called INCB054828
Pemigatinib will be taken orally with a targeted starting does of 13.5 mg
Computed Tomography (CT)Procedure or surgery
Also called CT scan, CAT Scan, computerized tomography
Undergo CT scan
Magnetic Resonance ImagingProcedure or surgery
Also called MRI, nuclear magnetic resonance imaging, NMRI, Magnetic Resonance Tomography
Undergo MRI
Optical Coherence TomographyProcedure or surgery
Also called OCT
Undergo OCT
Bone ScanProcedure or surgery
Also called Bone Scintigraphy
Undergo whole body bone scan
OphthalmoscopyProcedure or surgery
Also called FS, Fundoscopy
Undergo dilated ophthalmoscopy
| Study group | Role | What they receive |
|---|---|---|
| Pemigatinib Treament | Experimental | Patients 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. Receives: Drug: Pemigatinib; Procedure: Computed Tomography (CT); Procedure: Magnetic Resonance Imaging; Procedure: Optical Coherence Tomography; Procedure: Bone Scan; Procedure: Ophthalmoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 24 months
Secondary outcomes (5)
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
Type, frequency and severity of adverse events
The severity of AEs will be assessed according to the NCI CTCAE v5.0
Measured: Up to 12 months
Best overall response (BOR)
BOR will be summarized for each cohorts using the ORR and the Disease Control Rate which are the proportion of patients having respectively a best overall response of partial response (PR) or complete response (CR), or stable disease (SD), PR or CR. The estimated ORR and corresponding 95% confidence intervals based on the binomial distribution will be reported.
Measured: Baseline up to 1 year after completion of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start26 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sameek Roychowdhury
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor-investigator, Sameek Roychowdhury, Ohio State University Comprehensive Cancer Center
- Investigators
- Sameek Roychowdhury, MD, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906562
- Sponsor's protocol ID
- OSU-23382
- Other IDs
- NCI-2025-03043
- Status last verified
- Feb 2026
- First submitted
- 26 Mar 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No