A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
- Conditions
- Interventions
- Registration Number
- NCT06406465
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
Background:
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- Detailed Description
Background:
* Poorly differentiated neuroendocrine carcinomas (NECs) are all high-grade carcinomas that resemble small cell carcinoma or large cell NEC of the lung. Poorly differentiated NECs are often associated with a rapidly progressive disease and a proliferative rate (Ki67%) \>20%.
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Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Belinostat Belinostat at 400 mg/m\^2/day plus Cisplatin plus Etoposide Arm 1 Cisplatin Belinostat at 400 mg/m\^2/day plus Cisplatin plus Etoposide Arm 1 Etoposide Belinostat at 400 mg/m\^2/day plus Cisplatin plus Etoposide Arm 2 Belinostat Belinostat at 600 mg/m\^2/day plus Cisplatin plus Etoposide Arm 2 Cisplatin Belinostat at 600 mg/m\^2/day plus Cisplatin plus Etoposide Arm 2 Etoposide Belinostat at 600 mg/m\^2/day plus Cisplatin plus Etoposide
- Primary Outcome Measures
Name Time Method 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 ... Cycles 1-6 pre- and post- treatment with belinostat with all doses Identified as the PK parameter of interest.
- Secondary Outcome Measures
Name Time Method To assess duration of response of belinostat maintenance Every 9 weeks while on monotherapy. Total study therapy will not exceed 5 years. Duration of response will be calculated by the Kaplan-Meier method, starting at date response was identified until progression or the response is declared to have ended, if the participants have a PR or CR.
To assess duration of response of belinostat administered as a continuous 48 h infusion in combination with cisplatin and etoposide in platinum sensitive Until progression or the response is declared to have ended , if the participants have a PR or CR. Until 3 years after last participant enrolled. Duration of response will be calculated by the Kaplan-Meier method, starting at date response was identified until progression or the response is declared to have ended, if the participants have a PR or CR.
To determine efficacy with respect to objective response rate of belinostat administered as a continuous 48 h infusion in combination with cisplatin and etoposide Every 9 weeks while on study therapy Objective response rate will be assessed by CT/MRI scans, calculated by Kaplan-Meier method, reporting the median values of each.
To determine the progression-free survival (PFS) and overall survival (OS) of belinostat administered as a continuous 48 h infusion in combination with cisplatin and etoposide PFS will be assessed from on-study date until date of progression or death without progression. Overall survival (OS) will be calculated from the on-study date until date of death. Until 3 years after last participant enrolled. Progression free survival and overall survival calculated by Kaplan-Meier method, reporting the median values of each.
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States