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NCT06406465 · ClinicalTrials.gov registry record · Phase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
A Phase 2 study of Neuroendocrine Carcinoma and Carcinoma, Neuroendocrine, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06406465: Recruiting Phase 2 study of Neuroendocrine Carcinoma and Carcinoma, Neuroendocrine, sponsored by National Cancer Institute (NCI).
NCT06406465 is a Phase 2 study of Neuroendocrine Carcinoma and Carcinoma, Neuroendocrine that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 276-participant average among 13 other Neuroendocrine Carcinoma trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06406465, a Phase 2 study of Neuroendocrine Carcinoma and Carcinoma, Neuroendocrine, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Identified as the PK parameter of interest.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Etoposide
- DRUG Belinostat
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-03-26 |
| Est. Completion | 2028-07-30 |
| Phase | Phase 2 |
What NCT06406465 shows while recruiting
NCT06406465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 276-participant average among 13 other Neuroendocrine Carcinoma trials with a reported enrollment target (78% lower).
The record links to 5 conditions, with Neuroendocrine Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.
NCT06406465 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06406465 about?
NCT06406465 is a clinical study titled "A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity". 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 ha...
What is the current status of trial NCT06406465?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-03-26. Estimated completion is 2028-07-30.
What conditions does trial NCT06406465 study?
This clinical trial studies the following conditions: Neuroendocrine Carcinoma, Carcinoma, Neuroendocrine, Tumor, Neuroendocrine, Tumors, Neuroendocrine, Small Cell; Receptors.
What interventions are being tested in trial NCT06406465?
The interventions under investigation include: Cisplatin (DRUG), Etoposide (DRUG), Belinostat (DRUG).
Who is sponsoring clinical trial NCT06406465?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06406465 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06406465's enrollment target sits among peer trials
60 7th of 13 higher than 7 of 13 other Neuroendocrine Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroendocrine Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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