A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pemigatinib — DRUG
  Pemigatinib will be taken orally with a targeted starting does of 13.5 mg
• Computed Tomography (CT) — PROCEDURE
  Undergo CT scan
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Optical Coherence Tomography — PROCEDURE
  Undergo OCT
• Bone Scan — PROCEDURE
  Undergo whole body bone scan
• Ophthalmoscopy — PROCEDURE
  Undergo dilated ophthalmoscopy

Study Details

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.

Key Dates

Start date

Aug 26, 2025

Status verified

Feb 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Pemigatinib Treament
  Patients receive pemigatinib PO 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, CT and/or MRI, and OCT throughout the study. Patients may also undergo whole body bone scans and dilated fundoscopy as clinically indicated.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 24 months ]

Central Contacts

• Sameek Roychowdhury, MD, PhD
  734-474-8359
  [email protected]
• The Ohio State University Comprehensive Cancer Center and James Cancer Hospital
  [email protected]

Locations (109)

Find similar trials in Birmingham, AL

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