Actively Recruiting
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
Led by Sameek Roychowdhury · Updated on 2026-02-17
40
Participants Needed
109
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Sameek Roychowdhury
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of pemigatinib for adults with advanced or metastatic pancreatic cancer that has spread locally or to distant parts of the body. This study focuses on patients whose cancer has specific abnormal changes in the FGFR gene, which can promote cancer growth. The goal is to see if pemigatinib can block these abnormal genes to stop tumor growth and improve quality of life. Participants take pemigatinib orally once daily for 14 days in each 21-day cycle, continuing as long as the cancer does not worsen or side effects are manageable. During the study, patients undergo blood tests, CT and/or MRI scans, and optical coherence tomography (OCT). Additional scans like whole body bone scans and eye exams may be performed if needed. After treatment, patients are followed up 30 days later and then every 4 months for one year. Throughout the study, researchers assess tumor response using imaging and blood tests, including monitoring cell-free DNA to track response and resistance. They measure overall response rate up to 24 months and evaluate progression-free survival, disease control, overall survival, and side effects up to 12 months. Safety and tolerability are closely monitored, and patients' overall health and treatment effects are regularly checked to understand the impact of pemigatinib.
CONDITIONS
Brief Title
A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Diagnosed with advanced or metastatic pancreatic cancer of any histologic type
- Documented FGFR gene fusions, translocations, or activating mutations confirmed by a certified laboratory
- Measurable or evaluable disease based on RECIST version 1.1
- Have progressed on or are intolerant to at least one standard of care therapy for advanced/metastatic pancreatic cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (status of 2 may be considered case-by-case)
- Able to understand and provide written informed consent
- Recovered from prior cancer therapy side effects to baseline or Grade 1, except alopecia and stable neuropathy up to Grade 2
- Able to swallow and retain oral medication
- Willing and able to comply with study visits and procedures
You will not qualify if you...
- Neurological symptoms requiring increasing corticosteroid doses
- History of another primary cancer unless adequately treated and not expected to affect survival or require treatment during the study
- Any medical condition that would prevent safe participation or compliance
- Current corneal or retinal disorders confirmed by eye exam
- History or evidence of extensive tissue calcification except minor or asymptomatic findings
- Gastrointestinal conditions that affect absorption of oral medication
- Altered calcium/phosphate metabolism disorders
- Recent anticancer treatments within specified timeframes before study drug
- Use of strong CYP3A4 inducers or inhibitors and certain medications affecting phosphorus or calcium
- Consumption of grapefruit or related products within 7 days before first dose
- Low blood counts below specified thresholds
- Liver function tests above specified limits unless related to cancer with investigator approval
- Creatinine clearance below 40 mL/min
- Abnormal serum phosphorus or calcium levels
- Significant or uncontrolled heart disease
- Pregnant or nursing women
- Women of childbearing potential not using highly effective contraception
- Sexually active males not using condoms during and for 3 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive the study drug pemigatinib orally once daily on days 1 to 14 of each 21-day cycle. Treatment continues until disease progression or unacceptable side effects occur. Participants undergo blood sample collection, CT and/or MRI scans, and OCT imaging throughout treatment. Additional procedures such as whole body bone scans and dilated fundoscopy may be performed as clinically indicated.
Visits every 3 weeks for treatment and assessments
Duration - Up to 1 year after treatment completion
After completing study treatment, participants are followed up to monitor health and response to therapy. Follow-up visits include assessments at 30 days after treatment ends, then every 4 months for one year.
1 visit at 30 days post-treatment, then visits every 4 months for 12 months
Trial Site Locations
Total: 109 locations
1
Ohio State University-Telemedicine
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
Ohio State University-Telemedicine
Mobile, Alabama, United States, 36604
Actively Recruiting
3
Ohio State University Telemedicine
Montgomery, Alabama, United States, 36104
Actively Recruiting
4
Ohio State University-Telemedicine
Anchorage, Alaska, United States, 99508
Actively Recruiting
5
Ohio State University Telemedicine
Flagstaff, Arizona, United States, 86001
Actively Recruiting
6
Ohio State University-Telemedicine
Phoenix, Arizona, United States, 85054
Actively Recruiting
7
Ohio State University-Telemedicine
Tucson, Arizona, United States, 85719
Actively Recruiting
8
Ohio State University-Telemedicine
Hot Springs, Arkansas, United States, 71913
Actively Recruiting
9
Ohio State University Telemedicine
Fresno, California, United States, 87901
Actively Recruiting
10
Ohio State University-Telemedicine
Los Angeles, California, United States, 91010
Actively Recruiting
11
Ohio State University-Telemedicine
San Diego, California, United States, 92037
Actively Recruiting
12
Ohio State University-Telemedicine
San Francisco, California, United States, 94143
Actively Recruiting
13
Ohio State University-Telemedicine
Aurora, Colorado, United States, 80045
Actively Recruiting
14
Ohio State University Telemedicine
Denver, Colorado, United States, 80202
Actively Recruiting
15
Ohio State University Telemedicine
Durango, Colorado, United States, 81301
Actively Recruiting
16
Ohio State University Telemedicine
Grand Junction, Colorado, United States, 81501
Actively Recruiting
17
Ohio State University-Telemedicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
18
Ohio State University-Telemedicine
Wilmington, Delaware, United States, 19713
Actively Recruiting
19
Ohio State University-Telemedicine
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
20
Ohio State University-Telemedicine
Jacksonville, Florida, United States, 32207
Actively Recruiting
21
Ohio State University-Telemedicine
Miami, Florida, United States, 33136
Actively Recruiting
22
Ohio State University-Telemedicine
Orlando, Florida, United States, 32806
Actively Recruiting
23
Ohio State University Telemedicine
Tallahassee, Florida, United States, 32301
Actively Recruiting
24
Ohio State University-Telemedicine
Tampa, Florida, United States, 33612
Actively Recruiting
25
Ohio State University-Telemedicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
26
Ohio State University-Telemedicine
Augusta, Georgia, United States, 30912
Actively Recruiting
27
Ohio State University-Telemedicine
Honolulu, Hawaii, United States, 96813
Actively Recruiting
28
Ohio State University-Telemedicine
Boise, Idaho, United States, 83706
Actively Recruiting
29
Ohio State University Telemedicine
Lewiston, Idaho, United States, 83501
Actively Recruiting
30
Ohio State University-Telemedicine
Champaign, Illinois, United States, 61801
Actively Recruiting
31
Ohio State University-Telemedicine
Chicago, Illinois, United States, 60637
Actively Recruiting
32
Ohio State University Telemedicine
Quincy, Illinois, United States, 62301
Actively Recruiting
33
Ohio State University Telemedicine
Evansville, Indiana, United States, 44708
Actively Recruiting
34
Ohio State University-Telemedicine
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
35
Ohio State University-Telemedicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
36
Ohio State University-Telemedicine
Des Moines, Iowa, United States, 50314
Actively Recruiting
37
Ohio State University-Telemedicine
Iowa City, Iowa, United States, 52242
Actively Recruiting
38
Ohio State University Telemedicine
Colby, Kansas, United States, 67701
Actively Recruiting
39
Ohio State University-Telemedicine
Kansas City, Kansas, United States, 66160
Actively Recruiting
40
Ohio State University-Telemedicine
Wichita, Kansas, United States, 67206
Actively Recruiting
41
Ohio State University-Telemedicine
Lexington, Kentucky, United States, 40536
Actively Recruiting
42
Ohio State University Telemedicine
Lake Charles, Louisiana, United States, 70601
Actively Recruiting
43
Ohio State University-Telemedicine
New Orleans, Louisiana, United States, 70112
Actively Recruiting
44
Ohio State University Telemedicine
Shreveport, Louisiana, United States, 77101
Actively Recruiting
45
Ohio State University-Telemedicine
Bar Harbor, Maine, United States, 04609
Actively Recruiting
46
Ohio State University-Telemedicine
Baltimore, Maryland, United States, 21231
Actively Recruiting
47
Ohio State University-Telemedicine
Boston, Massachusetts, United States, 02215
Actively Recruiting
48
Ohio State University-Telemedicine
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
49
Ohio State University-Telemedicine
Detroit, Michigan, United States, 48201
Actively Recruiting
50
Ohio State University-Telemedicine
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
51
Ohio State University Telemedicine
Rochester, Minnesota, United States, 55901
Actively Recruiting
52
Ohio State University Telemedicine
Jackson, Mississippi, United States, 39201
Actively Recruiting
53
Ohio State University Telemedicine
Springfield, Missouri, United States, 65801
Actively Recruiting
54
Ohio State University-Telemedicine
St Louis, Missouri, United States, 63110
Actively Recruiting
55
Ohio State University-Telemedicine
Bozeman, Montana, United States, 59715
Actively Recruiting
56
Ohio State University Telemedicine
Miles City, Montana, United States, 59301
Actively Recruiting
57
Ohio State University Telemedicine
North Platte, Nebraska, United States, 69101
Actively Recruiting
58
Ohio State University-Telemedicine
Omaha, Nebraska, United States, 68105
Actively Recruiting
59
Ohio State University-Telemedicine
Las Vegas, Nevada, United States, 89166
Actively Recruiting
60
Ohio State University Telemedicine
Reno, Nevada, United States, 89501
Actively Recruiting
61
Ohio State University-Telemedicine
Concord, New Hampshire, United States, 03301
Actively Recruiting
62
Ohio State University-Telemedicine
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
63
Ohio State University Telemedicine
Roswell, New Mexico, United States, 88201
Actively Recruiting
64
Ohio State University-Telemedicine
Albany, New York, United States, 12208
Actively Recruiting
65
Ohio State University Telemedicine
Buffalo, New York, United States, 14021
Actively Recruiting
66
Ohio State University-Telemedicine
New York, New York, United States, 10065
Actively Recruiting
67
Ohio State University-Telemedicine
Syracuse, New York, United States, 13210
Actively Recruiting
68
Ohio State University-Telemedicine
Charlotte, North Carolina, United States, 28204
Actively Recruiting
69
Ohio State University-Telemedicine
Raleigh, North Carolina, United States, 27614
Actively Recruiting
70
Ohio State University-Telemedicine
Bismarck, North Dakota, United States, 58701
Actively Recruiting
71
Ohio State University-Telemedicine
Fargo, North Dakota, United States, 58103
Actively Recruiting
72
Ohio State University-Telemedicine
Cincinnati, Ohio, United States, 45219
Actively Recruiting
73
Ohio State University-Telemedicine
Cleveland, Ohio, United States, 44195
Actively Recruiting
74
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
75
Ohio State University-Telemedicine
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
76
Ohio State University Telemedicine
Eugene, Oregon, United States, 97401
Actively Recruiting
77
Ohio State University-Telemedicine
Portland, Oregon, United States, 97239
Actively Recruiting
78
Ohio State University-Telemedicine
Philadelphia, Pennsylvania, United States, 48109
Actively Recruiting
79
Ohio State University-Telemedicine
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
80
Ohio State University
Wellsboro, Pennsylvania, United States, 16901
Actively Recruiting
81
Ohio State University-Telemedicine
Charleston, South Carolina, United States, 29425
Actively Recruiting
82
Ohio State University Telemedicine
Rapid City, South Dakota, United States, 57701
Actively Recruiting
83
Ohio State University Telemedicine
Sioux Falls, South Dakota, United States, 57101
Actively Recruiting
84
Ohio State University Telemedicine
Knoxville, Tennessee, United States, 37901
Actively Recruiting
85
Ohio State University-Telemedicine
Memphis, Tennessee, United States, 38119
Actively Recruiting
86
Ohio State University-Telemedicine
Nashville, Tennessee, United States, 37232
Actively Recruiting
87
Ohio State University Telemedicine
Amarillo, Texas, United States, 79101
Actively Recruiting
88
Ohio State University-Telemedicine
Austin, Texas, United States, 78745
Actively Recruiting
89
Ohio State University-Telemedicine
Dallas, Texas, United States, 75208
Actively Recruiting
90
Ohio State University Telemedicine
Fort Stockton, Texas, United States, 79735
Actively Recruiting
91
Ohio State University-Telemedicine
Houston, Texas, United States, 77030
Actively Recruiting
92
Ohio State University Telemedicine
Midland, Texas, United States, 79706
Actively Recruiting
93
Ohio State University-Telemedicine
San Antonio, Texas, United States, 78229
Actively Recruiting
94
Ohio State University Telemedicine
Cedar City, Utah, United States, 84720
Actively Recruiting
95
Ohio State University-Telemedicine
Salt Lake City, Utah, United States, 84112
Actively Recruiting
96
Ohio State University-Telemedicine
Burlington, Vermont, United States, 05401
Actively Recruiting
97
Ohio State University-Telemedicine
Norfolk, Virginia, United States, 02301
Actively Recruiting
98
Ohio State University-Telemedicine
Richmond, Virginia, United States, 23298
Actively Recruiting
99
Ohio State University Telemedicine
Roanoke, Virginia, United States, 24011
Actively Recruiting
100
Ohio State University-Telemedicine
Seattle, Washington, United States, 98109
Actively Recruiting
101
Ohio State University Telemedicine
Spokane, Washington, United States, 99201
Actively Recruiting
102
Ohio State University Telemedicine
Huntington, West Virginia, United States, 25701
Actively Recruiting
103
Ohio State University-Telemedicine
Morgantown, West Virginia, United States, 26506
Actively Recruiting
104
Ohio State University Telemedicine
Chippewa Falls, Wisconsin, United States, 54729
Actively Recruiting
105
Ohio State University Telemedicine
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
106
Ohio State University Telemedicine
Madison, Wisconsin, United States, 53701
Actively Recruiting
107
Ohio State University-Telemedicine
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
108
Ohio State University Telemedicine
Cheyenne, Wyoming, United States, 82001
Actively Recruiting
109
Ohio State University Telemedicine
Jackson, Wyoming, United States, 83003
Actively Recruiting
Research Team
S
Sameek Roychowdhury, MD, PhD
T
The Ohio State University Comprehensive Cancer Center and James Cancer Hospital
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here