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Belinostat, Cisplatin, and Etoposide for High-Grade Neuroendocrine Cancers

This study is for people aged 18 and older with high-grade neuroendocrine cancers (HGNENs) that have spread or can't be treated with standard methods. Researchers are testing if adjusting the dose of belinostat, a cancer drug, based on your UGT1A1 gene type can help your body process the medicine better. Belinostat will be given with two other cancer drugs, cisplatin and etoposide. The goal is to see if these dose adjustments can lead to more consistent levels of belinostat in your body over six treatment cycles. This study is currently recruiting about 60 participants, but its overall status is unclear.

Study design
This study plans to enroll 60 participants and will adjust belinostat dosing based on a participant's UGT1A1 gene type.
What's involved
Participants will undergo screening, including a physical exam, blood tests (some for genetic testing), imaging scans, and a heart function test.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured over six treatment cycles, looking at drug levels before and after belinostat administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06406465

A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity

Recruiting
PHASE2Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~60 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:BelinostatCisplatinEtoposide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine if pharmacogenomic intervention can normalize the area under the curve (AUC) at cycle 6 between UGT1A1*28 and UGT1A1*60 genotypes) of belinostat administered as a continuous 48 h infusion in combination with cisplatin and etoposide
Measured over Cycles 1-6 pre- and post- treatment with belinostat with all doses

Conditions

Carcinoma, Neuroendocrine
Tumor, Neuroendocrine
Tumors, Neuroendocrine
Neuroendocrine; Carcinoma
Small Cell; Receptors

Explore related trials

Neuroendocrine NeoplasmUGT1A1 Gene

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Jaydira Del Rivero, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Anna Liza F Rivero
[email protected]
(240) 858-7946
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Leukocytes \>=3,000/mcL
Hemoglobin \>= 10 g/dL
Absolute neutrophil count (ANC) \>=1,500/mcL
Platelets \>=100,000/mcL
Aspartate aminotransferase (AST) or serum glutamic-oxaloacetic transaminase (SGOT) / Alanine aminotransferase (ALT) or serum glutamic-pyruvic transaminase (SGPT): \<=3 X institutional upper limit of normal
Total bilirubin \<= 1.5 x institutional upper limit of normal (ULN).
Serum Creatinine \<= 1.5 X institutional ULN OR
An estimated Creatinine clearance (CrCL) \>=60 mL/min/1.73 m\^2 based on the Cockcroft Gault equation
Prothrombin time (PT) / International normalized ratio (INR) and Partial thromboplastin time (PTT) \<= 1 X institutional ULN 8. Hepatitis B virus (HBV)-infected participants can be enrolled if HBV DNA is undetectable. Hepatitis C virus (HCV)-infected participants can be enrolled if HCV RNA level is undetectable 9. Women of child-bearing potential (WOCBP) must agree to use effective contraception (hormonal, intrauterine device (IUD), tube ligation, a partner has had a previous vasectomy, abstinence) prior to study entry, during the study, and for 14 months for women after the last dose of the study drug(s). Men with partners of childbearing potential must agree to use effective contraception (abstinence, condoms, previous vasectomy) or request partners to use effective contraception (per above) during the study and for 11 months after the last dose of study therapy. 10. Breastfeeding participants must be willing to discontinue breastfeeding starting with prior to study entry, during the study, and for 3 months after the last dose of the study drug(s). 11. Willing to comply with study procedures and follow-up. 12. Participants must be able to understand and be willing to sign a written informed consent document.

What this trial measures

  • To determine if pharmacogenomic intervention can normalize the area under the curve (AUC) at cycle 6 between UGT1A1*28 and UGT1A1*60 genotypes) of belinostat administered as a continuous 48 h infusion in combination with cisplatin and etoposideCycles 1-6 pre- and post- treatment with belinostat with all doses

    Identified as the PK parameter of interest.