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New hope for pancreatic cancer: targeted pill studied in nationwide telemedicine trial

NCT ID NCT06906562

Disease control Sponsor: Sameek Roychowdhury Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called pemigatinib in people with advanced or metastatic pancreatic cancer that has certain changes in the FGFR gene. The drug aims to block these abnormal genes and stop tumor growth. About 40 adults will take the pill at home and be monitored through telemedicine visits. The goal is to see if the treatment can shrink tumors and improve quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 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 Exclusion Criteria * 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 * 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

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Conditions

The condition(s) this trial relates to.

exocrine pancreatic carcinoma malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced pancreatic carcinoma Metastatic pancreatic carcinoma Stage II pancreatic cancer ajcc V8 Stage III pancreatic cancer ajcc V8 Stage IV pancreatic cancer ajcc V8

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    109 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ohio State University

    RECRUITING

    Wellsboro, Pennsylvania, 16901, United States

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Ohio State University Telemedicine

    RECRUITING

    Montgomery, Alabama, 36104, United States

  • Ohio State University Telemedicine

    RECRUITING

    Flagstaff, Arizona, 86001, United States

  • Ohio State University Telemedicine

    RECRUITING

    Fresno, California, 87901, United States

  • Ohio State University Telemedicine

    RECRUITING

    Denver, Colorado, 80202, United States

  • Ohio State University Telemedicine

    RECRUITING

    Durango, Colorado, 81301, United States

  • Ohio State University Telemedicine

    RECRUITING

    Grand Junction, Colorado, 81501, United States

  • Ohio State University Telemedicine

    RECRUITING

    Tallahassee, Florida, 32301, United States

  • Ohio State University Telemedicine

    RECRUITING

    Lewiston, Idaho, 83501, United States

  • Ohio State University Telemedicine

    RECRUITING

    Quincy, Illinois, 62301, United States

  • Ohio State University Telemedicine

    RECRUITING

    Evansville, Indiana, 44708, United States

  • Ohio State University Telemedicine

    RECRUITING

    Colby, Kansas, 67701, United States

  • Ohio State University Telemedicine

    RECRUITING

    Lake Charles, Louisiana, 70601, United States

  • Ohio State University Telemedicine

    RECRUITING

    Shreveport, Louisiana, 77101, United States

  • Ohio State University Telemedicine

    RECRUITING

    Rochester, Minnesota, 55901, United States

  • Ohio State University Telemedicine

    RECRUITING

    Jackson, Mississippi, 39201, United States

  • Ohio State University Telemedicine

    RECRUITING

    Springfield, Missouri, 65801, United States

  • Ohio State University Telemedicine

    RECRUITING

    Miles City, Montana, 59301, United States

  • Ohio State University Telemedicine

    RECRUITING

    North Platte, Nebraska, 69101, United States

  • Ohio State University Telemedicine

    RECRUITING

    Reno, Nevada, 89501, United States

  • Ohio State University Telemedicine

    RECRUITING

    Roswell, New Mexico, 88201, United States

  • Ohio State University Telemedicine

    RECRUITING

    Buffalo, New York, 14021, United States

  • Ohio State University Telemedicine

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Ohio State University Telemedicine

    RECRUITING

    Rapid City, South Dakota, 57701, United States

  • Ohio State University Telemedicine

    RECRUITING

    Sioux Falls, South Dakota, 57101, United States

  • Ohio State University Telemedicine

    RECRUITING

    Knoxville, Tennessee, 37901, United States

  • Ohio State University Telemedicine

    RECRUITING

    Amarillo, Texas, 79101, United States

  • Ohio State University Telemedicine

    RECRUITING

    Fort Stockton, Texas, 79735, United States

  • Ohio State University Telemedicine

    RECRUITING

    Midland, Texas, 79706, United States

  • Ohio State University Telemedicine

    RECRUITING

    Cedar City, Utah, 84720, United States

  • Ohio State University Telemedicine

    RECRUITING

    Roanoke, Virginia, 24011, United States

  • Ohio State University Telemedicine

    RECRUITING

    Spokane, Washington, 99201, United States

  • Ohio State University Telemedicine

    RECRUITING

    Huntington, West Virginia, 25701, United States

  • Ohio State University Telemedicine

    RECRUITING

    Chippewa Falls, Wisconsin, 54729, United States

  • Ohio State University Telemedicine

    RECRUITING

    Green Bay, Wisconsin, 54301, United States

  • Ohio State University Telemedicine

    RECRUITING

    Madison, Wisconsin, 53701, United States

  • Ohio State University Telemedicine

    RECRUITING

    Cheyenne, Wyoming, 82001, United States

  • Ohio State University Telemedicine

    RECRUITING

    Jackson, Wyoming, 83003, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Mobile, Alabama, 36604, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Tucson, Arizona, 85719, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Hot Springs, Arkansas, 71913, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Los Angeles, California, 91010, United States

  • Ohio State University-Telemedicine

    RECRUITING

    San Diego, California, 92037, United States

  • Ohio State University-Telemedicine

    RECRUITING

    San Francisco, California, 94143, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Ohio State University-Telemedicine

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Wilmington, Delaware, 19713, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Miami, Florida, 33136, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Orlando, Florida, 32806, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Tampa, Florida, 33612, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Honolulu, Hawaii, 96813, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Boise, Idaho, 83706, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Champaign, Illinois, 61801, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Wichita, Kansas, 67206, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • Ohio State University-Telemedicine

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Bar Harbor, Maine, 04609, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Baltimore, Maryland, 21231, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Ohio State University-Telemedicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Bozeman, Montana, 59715, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Omaha, Nebraska, 68105, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Las Vegas, Nevada, 89166, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Concord, New Hampshire, 03301, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Albuquerque, New Mexico, 87102, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Albany, New York, 12208, United States

  • Ohio State University-Telemedicine

    RECRUITING

    New York, New York, 10065, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Syracuse, New York, 13210, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Raleigh, North Carolina, 27614, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Bismarck, North Dakota, 58701, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Fargo, North Dakota, 58103, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Portland, Oregon, 97239, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Philadelphia, Pennsylvania, 48109, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Austin, Texas, 78745, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Dallas, Texas, 75208, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Ohio State University-Telemedicine

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Burlington, Vermont, 05401, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Norfolk, Virginia, 02301, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Seattle, Washington, 98109, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Ohio State University-Telemedicine

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

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