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
Sameek Roychowdhury
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.
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 s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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)…
Interventions
- DrugPemigatinib
Pemigatinib will be taken orally with a targeted starting does of 13.5 mg
- ProcedureComputed Tomography (CT)
Undergo CT scan
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureOptical Coherence Tomography
Undergo OCT
- ProcedureBone Scan
Undergo whole body bone scan
- ProcedureOphthalmoscopy
Undergo dilated ophthalmoscopy
Locations (109)
- Ohio State University-TelemedicineBirmingham, Alabama
- Ohio State University-TelemedicineMobile, Alabama
- Ohio State University TelemedicineMontgomery, Alabama
- Ohio State University-TelemedicineAnchorage, Alaska
- Ohio State University TelemedicineFlagstaff, Arizona
- Ohio State University-TelemedicinePhoenix, Arizona