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

First listed
May 9, 2024
Start date
Jul 21, 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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