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NCT03154281 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast
A Phase 1 study, sponsored by Avera McKennan Hospital & University Health Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT03154281: Completed Phase 1 study, sponsored by Avera McKennan Hospital & University Health Center.
NCT03154281 is a Phase 1 study that has completed, run by Avera McKennan Hospital & University Health Center. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03154281, a Phase 1 study, has completed, sponsored by Avera McKennan Hospital & University Health Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
Open-label, cohort study to determine the feasibility and tolerability of the combination of daily niraparib and daily or thrice weekly everolimus for one 28-day cycle in patients with advanced ovarian and breast cancer.
Primary Outcome
The DLT criteria for adverse events occurring in Cycle 1 while determining the maximum tolerated dose (MTD) are described in the protocol. The number of patients who experience DLT from the trial treatment is recorded.
Interventions
- DRUG everolimus
- DRUG niraparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2017-07-26 |
| Est. Completion | 2023-05-01 |
| Phase | Phase 1 |
What the finished NCT03154281 record still lists
NCT03154281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which everolimus is the first listed.
NCT03154281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03154281 about?
NCT03154281 is a clinical study titled "Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast". Open-label, cohort study to determine the feasibility and tolerability of the combination of daily niraparib and daily or thrice weekly everolimus for one 28-day cycle in patients with advanced ovarian and breast cancer.
What is the current status of trial NCT03154281?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2017-07-26. Estimated completion is 2023-05-01.
What interventions are being tested in trial NCT03154281?
The interventions under investigation include: everolimus (DRUG), niraparib (DRUG).
Who is sponsoring clinical trial NCT03154281?
This trial is sponsored by Avera McKennan Hospital & University Health Center, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03154281's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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