NCT06906562ClinicalTrials.gov

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 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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

שלב 2דרושים 40 משתתפים109 אתריםמדינה אחת

קטגוריות

אונקולוגיה65%גסטרואנטרולוגיה והפטולוגיה31%אנדוקריני ומטבולי3%

רשום במרשם אחד

ClinicalTrials.govNCT06906562פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני חודשיים

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2025-04-02; recorded start 2025-08-26
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Not stated: No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (Sameek Roychowdhury)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 5 conditions.
Lead sponsor type recorded as: other.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 109 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleSMALL

A small study: 40 participants (target), run at 109 sites.

How this score is built

Enrolment14/40
40 participants (target)
Site count23/25
109 sites
Country count0/15
Single country
Planned duration8/10
Planned over about 41 months
Sponsor scale0/10
Sameek Roychowdhury has led 1 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

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.

PRIMARY OBJECTIVES: I. 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: I. 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: I. 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.

מצבים רפואיים

Advanced Pancreatic Carcinoma
Metastatic Pancreatic Carcinoma
Stage II Pancreatic Cancer AJCC v8
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8

זכאות

זכאות
מין	הכול
גילאים	18 Years – ללא מקסימום
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	שלב 2
הקצאה	לא רלוונטי
מודל ההתערבות	SINGLE_GROUP
מטרה ראשית	TREATMENT
הסתרה	NONE (0)
גיוס	דרושים 40 משתתפים

נותן חסות ושותפים

Sameek Roychowdhury נותן חסות
Incyte Corporation שותפים

זרועות והתערבויות

Pemigatinib TreamentEXPERIMENTAL
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.

התערבויות

פרוצדורה Bone Scan
Undergo whole body bone scan
פרוצדורה Computed Tomography (CT)
Undergo CT scan
פרוצדורה Magnetic Resonance Imaging
Undergo MRI
פרוצדורה Ophthalmoscopy
Undergo dilated ophthalmoscopy
פרוצדורה Optical Coherence Tomography
Undergo OCT
תרופה Pemigatinib
Pemigatinib will be taken orally with a targeted starting does of 13.5 mg

מדדי תוצאה

מדד תוצאה ראשוני
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
מסגרת זמן Up to 24 months
מדד תוצאה משני
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.
מסגרת זמן Up to 12 months
מדד תוצאה משני
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.
מסגרת זמן Up to 12 months
מדד תוצאה משני
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.
מסגרת זמן Up to 12 months
מדד תוצאה משני
Type, frequency and severity of adverse events
The severity of AEs will be assessed according to the NCI CTCAE v5.0
מסגרת זמן Up to 12 months
מדד תוצאה משני
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.
מסגרת זמן Baseline up to 1 year after completion of study treatment.

תאריכים

תאריכים
תאריך התחלה	26 באוגוסט 2025 (בפועל)
סיום ראשוני	31 בדצמבר 2026 (משוער)
סיום	31 בדצמבר 2028 (משוער)
פורסם לראשונה	2 באפריל 2025 (בפועל)
עודכן לאחרונה	17 בפברואר 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	פברואר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

109 אתרים מגייסים

United States

United States
מתקן	עיר	מדינה או אזור	מצב
Ohio State University-Telemedicine	Albany	New York	מגייס
Ohio State University-Telemedicine	Albuquerque	New Mexico	מגייס
Ohio State University Telemedicine	Amarillo	Texas	מגייס
Ohio State University-Telemedicine	Anchorage	Alaska	מגייס
Ohio State University-Telemedicine	Ann Arbor	Michigan	מגייס
Ohio State University-Telemedicine	Atlanta	Georgia	מגייס
Ohio State University-Telemedicine	Augusta	Georgia	מגייס
Ohio State University-Telemedicine	Aurora	Colorado	מגייס
Ohio State University-Telemedicine	Austin	Texas	מגייס
Ohio State University-Telemedicine	Baltimore	Maryland	מגייס
Ohio State University-Telemedicine	Bar Harbor	Maine	מגייס
Ohio State University-Telemedicine	Birmingham	Alabama	מגייס
Ohio State University-Telemedicine	Bismarck	North Dakota	מגייס
Ohio State University-Telemedicine	Boise	Idaho	מגייס
Ohio State University-Telemedicine	Boston	Massachusetts	מגייס
Ohio State University-Telemedicine	Bozeman	Montana	מגייס
Ohio State University Telemedicine	Buffalo	New York	מגייס
Ohio State University-Telemedicine	Burlington	Vermont	מגייס
Ohio State University Telemedicine	Cedar City	Utah	מגייס
Ohio State University-Telemedicine	Champaign	Illinois	מגייס
Ohio State University-Telemedicine	Charleston	South Carolina	מגייס
Ohio State University-Telemedicine	Charlotte	North Carolina	מגייס
Ohio State University Telemedicine	Cheyenne	Wyoming	מגייס
Ohio State University-Telemedicine	Chicago	Illinois	מגייס
Ohio State University Telemedicine	Chippewa Falls	Wisconsin	מגייס
Ohio State University-Telemedicine	Cincinnati	Ohio	מגייס
Ohio State University-Telemedicine	Cleveland	Ohio	מגייס
Ohio State University Telemedicine	Colby	Kansas	מגייס
Ohio State University Comprehensive Cancer Center	Columbus	Ohio	מגייס
Ohio State University-Telemedicine	Concord	New Hampshire	מגייס
Ohio State University-Telemedicine	Dallas	Texas	מגייס
Ohio State University Telemedicine	Denver	Colorado	מגייס
Ohio State University-Telemedicine	Des Moines	Iowa	מגייס
Ohio State University-Telemedicine	Detroit	Michigan	מגייס
Ohio State University Telemedicine	Durango	Colorado	מגייס
Ohio State University Telemedicine	Eugene	Oregon	מגייס
Ohio State University Telemedicine	Evansville	Indiana	מגייס
Ohio State University-Telemedicine	Fargo	North Dakota	מגייס
Ohio State University Telemedicine	Flagstaff	Arizona	מגייס
Ohio State University Telemedicine	Fort Stockton	Texas	מגייס
Ohio State University-Telemedicine	Fort Wayne	Indiana	מגייס
Ohio State University Telemedicine	Fresno	California	מגייס
Ohio State University Telemedicine	Grand Junction	Colorado	מגייס
Ohio State University Telemedicine	Green Bay	Wisconsin	מגייס
Ohio State University-Telemedicine	Honolulu	Hawaii	מגייס
Ohio State University-Telemedicine	Hot Springs	Arkansas	מגייס
Ohio State University-Telemedicine	Houston	Texas	מגייס
Ohio State University Telemedicine	Huntington	West Virginia	מגייס
Ohio State University-Telemedicine	Indianapolis	Indiana	מגייס
Ohio State University-Telemedicine	Iowa City	Iowa	מגייס

59 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06906562