Actively Recruiting
PH 2 Pemigatinib in SDH-deficient GIST
Led by Dana-Farber Cancer Institute · Updated on 2026-04-21
24
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
G
Gateway for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
PH 2 Pemigatinib in SDH-deficient GIST
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed SDH-deficient gastrointestinal stromal tumor (GIST) that is locally advanced or metastatic and not suitable for surgery
- At least one measurable tumor lesion meeting size criteria by imaging or clinical exam
- Documented disease progression before enrolling in the study
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ and bone marrow function with specific blood count and liver function thresholds
- HIV-positive patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible
- Participants with controlled hepatitis B or cured hepatitis C infection
- Treated brain metastases allowed if no progression on follow-up imaging
- No invasive cancer within the past 5 years except certain treated skin or cervical cancers
- Completed prior cancer treatments at least 2 weeks ago (6 weeks for certain drugs)
- Recovered from any side effects of prior cancer treatments except hair loss
- Cardiac function classified as New York Heart Association class 2B or better
- QTc interval less than 450 msec
- Willing to follow study procedures and able to swallow pills
- Women of childbearing potential must have negative pregnancy tests within specified timeframes
- Ability and willingness to provide informed consent; those with impaired decision-making may participate with a legally authorized representative
You will not qualify if you...
- Currently receiving other investigational drugs
- Allergic reactions to pemigatinib or similar compounds
- Taking certain drugs that strongly interact with enzymes affecting pemigatinib metabolism
- Uncontrolled illnesses
- Psychiatric or social conditions limiting study compliance
- Women or men unwilling or unable to use contraception as required during and after treatment
- Previous treatment with an FGFR inhibitor
- History of severe vitamin D deficiency requiring high doses
- Elevated calcium or phosphate levels despite treatment within 2 weeks before starting study drug
- Eye conditions that could increase risk of toxicity such as active retinal disease or glaucoma
- Use of potent CYP3A4 inhibitors or inducers shortly before starting study drug
- History of soft tissue calcifications linked to calcium or phosphate abnormalities except due to aging or injury or other diseases
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
S
Suzanne George, MD
CONTACT
S
Suzanne George, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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