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
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Sameek Roychowdhury
Lead Sponsor
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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 andor 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
Research Team
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Sameek Roychowdhury, MD, PhD
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The Ohio State University Comprehensive Cancer Center and James Cancer Hospital
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