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NCT02680795 · ClinicalTrials.gov registry record · Phase 1
Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes
A Phase 1 study, sponsored by Acrotech Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT02680795: Completed Phase 1 study, sponsored by Acrotech Biopharma.
NCT02680795 is a Phase 1 study that has completed, run by Acrotech Biopharma. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02680795, a Phase 1 study, has completed, sponsored by Acrotech Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A1\*28 genotypes and wild-type UGT1A1 gene. Enrolled patients will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype
Primary Outcome
PK will be measured for area under the time-concentration curve (AUC), steady state volume of distribution (Vdss),PK will be measured for total body clearance (CLtot),PK will be measured for fraction excreted unchanged (fe), PK will be measured for renal clearance (CLren), PK will be measured for non-renal clearance (CLnonren), PK will be measured for peak concentration (Cmax),and half-life (t1/2)
Interventions
- DRUG Belinostat IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2016-04-27 |
| Est. Completion | 2020-07-21 |
| Phase | Phase 1 |
What the finished NCT02680795 record still lists
NCT02680795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Belinostat IV is the first listed.
NCT02680795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02680795 about?
NCT02680795 is a clinical study titled "Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes". This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A1\*28 genotypes and wild-type UGT1A1 gene. Enrolled patients will be assigned to 1 o...
What is the current status of trial NCT02680795?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2016-04-27. Estimated completion is 2020-07-21.
What interventions are being tested in trial NCT02680795?
The interventions under investigation include: Belinostat IV (DRUG).
Who is sponsoring clinical trial NCT02680795?
This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02680795's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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