Pemigatinib for Pancreatic Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sameek Roychowdhury

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study is designed to evaluate the efficacy of the targeted, selective panFGFR inhibitor Pemigatinib when administered as a single agent to patients with genetically selected advanced or metastatic pancreas cancer through assessment of the overall response rate. Additionally, this study will support the molecular characterization of this subset of pancreas cancer through correlative studies

Research Team

Sameek Roychowdhury, MD, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

Adults with advanced or metastatic pancreatic cancer that has specific genetic changes called FGFR alterations can join this trial. The study is looking for people whose cancer hasn't responded to standard treatments.

Inclusion Criteria

I can carry out all my self-care but not work activities.

I am 18 years old or older.

I have recovered from previous cancer treatments, except for hair loss or mild nerve damage.

Exclusion Criteria

I have treatment options available that are known to help my condition.

I need more steroids to manage my neurological symptoms.

I haven't taken specific cancer drugs before starting pemigatinib recently.

Treatment Details

Interventions

• Pemigatinib (Kinase Inhibitor)

Trial Overview The trial tests Pemigatinib, a drug targeting certain genes in cancer cells, to see how well it works on its own in treating pancreatic cancer. Participants will also undergo CT and MRI scans for detailed imaging of the tumor's response.

Participant Groups

Group I: Pemigatinib Treament Experimental Treatment 3 Interventions

Oral, monotherapy pemigatinib will be administered once daily for the first 2 weeks (14 days) followed by one week break of each 21-day cycle. Treatment period will begin on Cycle 1 Day 1 and will continue until disease progression, unacceptable toxicity, withdrawal of informed consent, or death. Patients will be evaluated for tumor response radiographically every 9 weeks until disease progression or discontinuation from study using RECIST v1.1.

Who Is Running the Clinical Trial?

Sameek Roychowdhury

Lead Sponsor

Trials

3

Recruited

40+

Incyte Corporation

Industry Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School