A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Recruiting
Phase 2
Interventional Study
Carcinoma, Neuroendocrine
Tumor, Neuroendocrine
Tumors, Neuroendocrine
Neuroendocrine; Carcinoma
Small Cell; Receptors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 120
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- National Cancer Institute (NCI) · NIH
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About This Trial
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 bett…
Trial Locations
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Eligibility Criteria
-INCLUSION CRITERIA:
1. Participants must have histologically confirmed diagnosis of Extrapulmonary High-Grade Neuroendocrine Neoplasms (HGNENs) for which there is no known standard therapy capable of extending life expectancy.
2. Age \>= 18 years.
3. Participants with neuroendocrine prostate cance…
Contacts