Entacapone Combination With Imatinib for Treatment of GIST (NCT04006769) | Clinical Trial Compass
CompletedEarly Phase 1
Entacapone Combination With Imatinib for Treatment of GIST
China5 participantsStarted 2020-10-30
Plain-language summary
This study evaluates the combination of entacapone and imatinib in the treatment of gastrointestinal stromal Tumors who have progressed on the setting of at least Imatinib and Sunitinib. 5 participants will be included in this open-label observatory study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Able to provide written informed consent and can understand and comply with the requirements of the study and the schedule of assessments.
✓. Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
✓. Expected life span \> 12 weeks.
✓. Histologically confirmed disease which is currently metastatic/unresectable gastrointestinal stroma tumor(GIST) of c-KIT E11 mutation genotype.
✓. Patients received imatinib as the first-line treatment and no progression within the first 6 months(no primary resistance to imatinib ). With disease progression following treatment with at least imatinib and sunitinib.
✓. Patients must be able to provide archival tumor tissues (approximately 4 \[at least 2\] unstained Formalin Fixed and Paraffin Embedded Tissues （FFPET）slides) for biomarker analysis to assess the expression of FTO and c-KIT protein.
✓. At least 1 measurable lesion (the longest diameter≥ 10mm). Note: Computed Tomography（CT） abdomen and pelvis with contrast including peritoneum, or positron emission tomography/computed tomography(PET/CT) performed skull base to knees or whole body before the first day of entacapone.
✓. Eastern Cooperative Oncology Group-performance status(ECOG PS) ≤ 2,or 3(the symptoms were definitely caused by GIST itself).
Exclusion criteria
✕. Age \< 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
What they're measuring
1
Adverse Events (AE) And Serious Adverse Events(SAE)
Timeframe: 36 months or 31 days after last dose, which come first.
Trial details
NCT IDNCT04006769
SponsorXiangya Hospital of Central South University
✕. Progression within the first 6 months of first-line imatinib treatment (primary imatinib resistance).
✕. Patients with active/symptomatic carrier or chronic hepatitis B virus (HBV) whose HBV DNA ≥ 1×104 copies/mL should be excluded. Note: Patients with detectable hepatitis B surface antigen(HBsAg) or HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at screening should have been treated for ≥2 weeks prior to written informed consent and should continue treatment for 6 months after study drug treatment discontinues.
✕. A known history of human immunodeficiency virus(HIV) infection.
✕. Malignancy other than GIST and still under the active treatment.
✕. Was administered a live vaccine ≤ 4 weeks before written informed consent.
✕. Any of the following medical conditions may threaten the safety of patients or affect the trial obedience including symptomatic heart failure requiring systematic treatment, unstable angina , acute myocardial infarction and severe chronic or active infections (including tuberculosis infection) requiring systemic antibacterial, antifungal, or antiviral therapy.
✕. History of severe hypersensitivity reactions to any ingredient of entacapone and imatinib.