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)
Who can participate
Age range18 Years
SexALL
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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.
* Participants must have radiographically documented progressive disease prior to study enrollment as per investigator assessment.
* Age ≥18 years
* ECOG performance status ≤2
* Participants must have adequate organ and marrow function as defined below:
* Hemoglobin \> 8 g/dL. Patients with a hemoglobin of 7.5-8.0 g/dL may be eligible if the value is chronic, there is no clinical evidence of active bleeding, and eligibility is confirmed upon review and approval of the Sponsor-Investigator
* Absolute neutrophil count ≥1,000/mcL
* platelets ≥100,000/mcL
* total bilirubin ≤1.5 × institutional upper limit of normal (ULN)
* AST(SGOT)/ALT(SGPT) ≤3.0 × institutional ULN (unless liver metastases are present in which case it must be ≤ 5 × ULN)
* glomerular filtration rate (GFR) ≥60 mL/min/1.73 m2 (using the CDK-EPI formula see Appendix B)
* Human immunodeficiency virus (HIV)-infected partici…
What they're measuring
1
Objective radiographic response rate
Timeframe: From first dose of pemigatinib until the date of objective response per RECIST 1.1 through study completion, an average of 1 year