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NCT02679131 · ClinicalTrials.gov registry record · Phase 1
To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment.
A Phase 1 study, sponsored by Acrotech Biopharma.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02679131 is a Phase 1 study that was terminated before completion, run by Acrotech Biopharma. The registered enrollment target is 18 participants.
The verdict
NCT02679131, a Phase 1 study, was terminated before completion, sponsored by Acrotech Biopharma.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
A phase I, open-label, nonrandomized study to determine the PK profile of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies in patients with renal impairment. Eligible patients will be assigned to 1 of 4 cohorts (A, B, C or D) based on their level of renal function (normal, mild, moderate, or severe renal impairment) and receive belinostat dose A for normal or mild renal impairment, and dose B for moderate or severe renal impairment.
Interventions
- DRUG Belinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2016-03 |
| Est. Completion | 2017-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02679131
The ClinicalTrials.gov registry entry for NCT02679131 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acrotech Biopharma, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Belinostat is the first listed.
NCT02679131 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02679131 about?
NCT02679131 is a clinical study titled "To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment.". A phase I, open-label, nonrandomized study to determine the PK profile of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies in patients with renal impairment. Eligible patients will be assigned to 1 of 4 cohorts (A, B, C or D) based on their level of renal fu...
What is the current status of trial NCT02679131?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2016-03. Estimated completion is 2017-06.
What interventions are being tested in trial NCT02679131?
The interventions under investigation include: Belinostat (DRUG).
Who is sponsoring clinical trial NCT02679131?
This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.
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