A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06406465
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Belinostat — DRUG
    400mg/m\^2/24h or 600 mg/m\^2/24h IV over (48h continuous infusion) on days 1, 2 and 3 based on UGT1A1 status
  • Cisplatin — DRUG
    60 mg/m\^2 IV over 60 minutes on day 2
  • Etoposide — DRUG
    80 mg/m\^2 IV over 60 minutes on day 2 after infusion of cisplatin and again on days 3 and 4

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
Jan 2026
Primary completion
Jul 30, 2027
Completion
Jul 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Belinostat at 400 mg/m\^2/day plus Cisplatin plus Etoposide
  • Experimental: Arm 2
    Belinostat at 600 mg/m\^2/day plus Cisplatin plus Etoposide

Primary Outcome Measure

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 [ Time Frame: Cycles 1-6 pre- and post- treatment with belinostat with all doses ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Anna Rivero
[email protected]
240-858-7946
NCI Medical Oncology Referral Office
[email protected]
(240) 760-6050

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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