NCT07434843

PH 2 Pemigatinib in SDH-deficient GIST

PEMIGIST: Phase 2 Study of Pemigatinib (INCB054828) in the Treatment of Patients With Advanced SDH-deficient Gastrointestinal Stromal Tumor (GIST)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine how effective the drug pemigatinib is as a treatment option for advanced succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors(GIST). This study will also assess the side effects associated with pemigatinib and evaluate its tolerability. The name of the study drug involved in this study is: • Pemigatinib (INCB054828)

Detailed description

This is a single-arm, open-label Phase 2 trial evaluating the clinical efficacy of pemigatinib (INCB054828) in patients with advanced succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors. The U.S. Food and Drug Administration (FDA) has not approved pemigatinib for advanced succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors but it has been approved for other uses. The research study procedures include screening for eligibility, study treatment in-clinic visits, physical exam, routine blood tests, pregnancy test, Electrocardiogram (ECG),Imaging Scans, Tumor sample, Data and biological specimen collection. Eligible participants will receive oral pemigatinib (INCB054828) continuously in 21-day cycles until disease progression or unacceptable toxicity. Follow up will begin 30 days after treatment stops. It is expected that about 24 people will take part in this research study. Incyte, a biopharmaceutical company, is supporting this research study by providing the study drug.

Conditions

• SDH Gene Mutation
• Gastrointestinal Stromal Tumor

Interventions

Type	Name	Description
DRUG	Pemigatinib	A selective Fibroblast Growth Factor Receptors inhibitor * Tablet taken orally

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-10-01
• Completion: 2029-04-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study