Actively Recruiting
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Led by National Cancer Institute (NCI) · Updated on 2026-05-14
60
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a confirmed diagnosis of Extrapulmonary High-Grade Neuroendocrine Neoplasms (HGNENs) without standard life-extending therapy
- Age 18 years or older
- Participants with neuroendocrine prostate cancer may continue ongoing LHRH agonist therapy
- Participants with bone metastases or hypercalcemia on prior intravenous bisphosphonate treatment may continue this therapy
- Must have measurable or non-measurable disease per RECIST 1.1
- ECOG performance status of 0 to 2 at screening
- Adequate organ and marrow function including leukocytes ≥3,000/mcL, hemoglobin ≥10 g/dL, ANC ≥1,500/mcL, platelets ≥100,000/mcL, liver enzymes ≤3 times upper limit of normal, total bilirubin ≤1.5 times upper limit of normal (≤3.0 times in Gilbert's syndrome), serum creatinine ≤1.5 times upper limit or creatinine clearance ≥60 mL/min/1.73 m², and coagulation times ≤1 times upper limit
- Participants with undetectable Hepatitis B or C viral loads
- Women of child-bearing potential must use effective contraception before, during, and after the study
- Men with partners of childbearing potential must use or require partners to use effective contraception during and after the study
- Breastfeeding participants must agree to stop breastfeeding before and during the study and for 3 months after last dose
- Willingness to comply with study procedures and follow-up
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior investigational drug, chemotherapy, immunotherapy, or radiotherapy (except palliative bone therapy) within 14 days before first treatment
- History of allergic reactions to belinostat, cisplatin, etoposide, or polysorbate 80
- Untreated or progressing brain metastases
- Unresolved significant adverse events from prior treatments except specified exceptions
- Use of strong UGT1A1 or CYP3A4 inhibitors or inducers not discontinued 5 half-lives before treatment
- Platinum-refractory disease
- Prior histone deacetylase inhibitor treatment within 2 weeks before enrollment
- Radiation to pelvis or bone marrow sites with inadequate bone marrow reserve
- Pregnancy
- Significant cardiovascular disease or unstable heart conditions
- Baseline prolonged QT/QTc interval or use of medications causing Torsade de Pointes
- HIV infection with CD4 count less than 200 cells/mm³
- Uncontrolled illnesses limiting study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Anna Liza F Rivero
CONTACT
J
Jaydira Del Rivero, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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