OncoMatch/Clinical Trials/NCT06406465
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Is NCT06406465 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Belinostat and Cisplatin for carcinoma, neuroendocrine.
Treatment: Belinostat · Cisplatin · Etoposide — Background: High-grade neuroendocrine carcinomas (HGNEC) are cancers that develop in different parts of the body, including the digestive tract, genitals, neck, and head. One drug (belinostat), combined with 2 other drugs (etoposide and cisplatin), is approved to treat HGNEC. But some people may have a gene variant that affects how quickly their body gets rid of the drug; these people may do better with different dosages of belinostat. Objective: To test higher or lower doses of belinostat based on gene variants in people with HGNEC. Eligibility: People aged 18 years and older with HGNEC. Design: Participants will be screened. They will have a physical exam with blood tests. Some blood will be used for genetic testing. They will have imaging scans and a test of their heart function. Samples of tumor tissue may be collected. All 3 study drugs (belinostat, etoposide, cisplatin) are given through a tube attached to a needle inserted into a vein. Treatment will be given in 21-day cycles. For cycles 1 through 6: Participants will come to the clinic for the first 4 days. They will be given all 3 drugs. Imaging scans and other tests will be repeated. Each visit will last 4 to 8 hours. After cycle 6: Participants may continue treatment with belinostat alone. They will come to the clinic for the first 3 days of each cycle. They may continue treatment for up to 5 years if the drug is helping them. Participants will have a follow-up visit 30 days after their last dose of belinostat. Then they will receive follow-up visits by phone or email every 3 to 6 months.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: investigational drug
prior investigational drug...within the past 14 days prior to the first drug administration
Cannot have received: chemotherapy
prior...chemotherapy...within the past 14 days prior to the first drug administration
Cannot have received: immunotherapy
prior...immunotherapy...within the past 14 days prior to the first drug administration
Cannot have received: radiotherapy
Exception: except for palliative bone directed therapy
prior...radiotherapy (except for palliative bone directed therapy) within the past 14 days prior to the first drug administration
Cannot have received: histone deacetylase inhibitor (valproic acid, vorinostat)
another histone deacetylase inhibitor (e.g., valproic acid, vorinostat) for at least 2 weeks prior to enrollment
Lab requirements
Blood counts
Leukocytes >=3,000/mcL; Hemoglobin >= 10 g/dL; ANC >=1,500/mcL; Platelets >=100,000/mcL
Kidney function
Serum Creatinine <= 1.5 X institutional ULN OR estimated Creatinine clearance (CrCL) >=60 mL/min/1.73 m^2 (Cockcroft Gault)
Liver function
AST/ALT <=3 X institutional ULN; total bilirubin <=1.5 X ULN (<=3.0 X ULN if Gilbert's syndrome)
Cardiac function
Prothrombin time (PT)/INR and PTT <= 1 X institutional ULN
Participants must have adequate organ and marrow function as defined below: Leukocytes >=3,000/mcL; Hemoglobin >= 10 g/dL; ANC >=1,500/mcL; Platelets >=100,000/mcL; AST/ALT <=3 X institutional ULN; total bilirubin <=1.5 X ULN (<=3.0 X ULN if Gilbert's syndrome); Serum Creatinine <= 1.5 X institutional ULN OR estimated Creatinine clearance (CrCL) >=60 mL/min/1.73 m^2 (Cockcroft Gault); Prothrombin time (PT)/INR and PTT <= 1 X institutional ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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