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NCT03206645 · ClinicalTrials.gov registry record · Phase 1
Unesbulin in Women With Ovarian Cancer Receiving Neoadjuvant Chemotherapy
A Phase 1 study, sponsored by University of Oklahoma.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT03206645: Completed Phase 1 study, sponsored by University of Oklahoma.
NCT03206645 is a Phase 1 study that has completed, run by University of Oklahoma. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03206645, a Phase 1 study, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This is an open-label Phase Ib dose-escalation study to determine the safety, tolerability, and pharmacokinetics of Unesbulin when combined with and following conventional chemotherapy and as maintenance therapy as a capsule (weight based dosing) and a tablet (fixed dosing) in women with epithelial ovarian, fallopian tube or primary peritoneal cancer which is previously untreated.
Primary Outcome
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of Unesbulin in combination with and following conventional chemotherapy and as maintenance as a capsule (weight-based dosing) and a tablet (fixed dosing). Standard chemotherapy will be comprised of carboplatin and weekly paclitaxel. The DLTs will be based on adverse events that occur during administration of the first 2 cycles of combination Unesbulin and chemotherapy (a cycle = 21 days).
Interventions
- DRUG Unesbulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-08-28 |
| Est. Completion | 2024-03-31 |
| Phase | Phase 1 |
What the finished NCT03206645 record still lists
NCT03206645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Unesbulin is the first listed.
NCT03206645 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03206645 about?
NCT03206645 is a clinical study titled "Unesbulin in Women With Ovarian Cancer Receiving Neoadjuvant Chemotherapy". This is an open-label Phase Ib dose-escalation study to determine the safety, tolerability, and pharmacokinetics of Unesbulin when combined with and following conventional chemotherapy and as maintenance therapy as a capsule (weight based dosing) and a tablet (fixed dosing) in women with epithelial ...
What is the current status of trial NCT03206645?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2017-08-28. Estimated completion is 2024-03-31.
What interventions are being tested in trial NCT03206645?
The interventions under investigation include: Unesbulin (DRUG).
Who is sponsoring clinical trial NCT03206645?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03206645's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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