Trial · NCT06406465
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
NCT06406465, Phase 2, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity. Trials, record NCT06406465. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06406465
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
- NCT number
- NCT06406465
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Carcinoma, Neuroendocrine, Tumor, Neuroendocrine, Tumors, Neuroendocrine, Neuroendocrine; Carcinoma, Small Cell; Receptors
- Interventions
- Belinostat, Cisplatin, Etoposide
- First posted
- 2024-05-09
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06406465
GET https://conductscience.org/api/trials/v1/NCT06406465/registered