A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations
NCT06906562 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-02-17
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 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.
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
Interventions
- DRUG
-
Pemigatinib
Pemigatinib will be taken orally with a targeted starting does of 13.5 mg
- PROCEDURE
-
Computed Tomography (CT)
Undergo CT scan
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- PROCEDURE
-
Optical Coherence Tomography
Undergo OCT
- PROCEDURE
-
Bone Scan
Undergo whole body bone scan
- PROCEDURE
-
Ophthalmoscopy
Undergo dilated ophthalmoscopy
Sponsors & Collaborators
- collaborator INDUSTRY
-
Sameek Roychowdhury
lead OTHER
Principal Investigators
-
Sameek Roychowdhury, MD, PhD · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-26
- Primary Completion
- 2026-12-31
- Completion
- 2028-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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