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PH 2 Pemigatinib in SDH-deficient GIST | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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)

NCT07434843•Dana-Farber Cancer Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
•* 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)
+12 more criteria

Exclusion Criteria

•Participants who are receiving any other investigational agents.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to pemigatinib (INCB054828).
•Concomitant administration with sensitive substrates/narrow therapeutic index drugs of CYP3A4, P-gp BCRP, MATE1, and MATE2K, and strong inhibitors and inducers of CYP3A4 should be avoided. Use caution with strong inhibitors and inducers of P-gp. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product. (See Appendix C Participant Drug Information Handout and Wallet Card).
•Participants with uncontrolled intercurrent illness.
•Participants with psychiatric illness/social situations that would limit compliance with study requirements.
•Women of childbearing potential unwilling or unable to perform contraception from screening until 4 months after completion of pemigatinib administration
•Men unwilling or unable to perform contraception from screening to until 4 months after completion of pemigatinib administration.
•Participants previously treated with a FGFR inhibitor.
•History of hypovitaminosis D requiring supraphysiologic doses (e.g., 50,000 UI/weekly or above). Vitamin D supplements are allowed.
•Participants with calcium and phosphate levels exceeding the upper limit of normal (ULN) despite medical intervention within 2 weeks prior to the first dose of pemigatinib.
+8 more criteria

Locations (1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

June 1, 2026

Primary Completion Date

October 1, 2028

Completion Date

April 1, 2029

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

SDH Gene MutationGastrointestinal Stromal Tumor

Interventions

Pemigatinib

DRUG

Contacts

Suzanne George, MD

CONTACT

617-632-5204 SGEORGE2@PARTNERS.ORG

Suzanne George, MD

CONTACT

617-632-5204

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PH 2 Pemigatinib in SDH-deficient GIST

Inclusion Criteria

Exclusion Criteria

Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Second-line Pharmacotherapy Patterns and Outcomes of Advanced Gastrointestinal Stromal Tumor: A Real-world Study

The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced GISTs

Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)

A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors