PEMIGIST: Phase 2 Study of Pemigatinib (INCB054828) in the Treatment of Patients With Advanced SDH-deficient Gastrointestinal Stromal Tumor (GIST)
Dana-Farber Cancer Institute
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)
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, Tu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must have histologically confirmed SDH-deficient GIST. Participants must have locally advanced or metastatic disease that is not amenable to surgery. * Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease. * Partic…
Interventions
- DrugPemigatinib
A selective Fibroblast Growth Factor Receptors inhibitor * Tablet taken orally
Location
- Dana Farber Cancer InstituteBoston, Massachusetts