OncoMatch/Clinical Trials/NCT06406465
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Is NCT06406465 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
Cancer type
Neuroendocrine Tumor
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06406465 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational drug, chemotherapy, immunotherapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 120 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages