NCT06906562

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sameek Roychowdhury · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

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

Type	Name	Description
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

Timeline

• Start date: 2025-08-26
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2025-04-02
• Last updated: 2026-02-17

Locations

109 sites across 1 country: United States

Regulatory

• FDA-regulated drug study