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NCT02540330 · ClinicalTrials.gov registry record · Phase 2
A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
A Phase 2 study, sponsored by Atossa Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT02540330 is a Phase 2 study that was terminated before completion, run by Atossa Therapeutics. The registered enrollment target is 3 participants.
The verdict
NCT02540330, a Phase 2 study, was terminated before completion, sponsored by Atossa Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The subsequent 5 subjects of each group will receive fulvestrant by intraductal instillation. All subjects will be monitored for systemic and local adverse events during the procedure, and following the procedure until mastectomy or lumpectomy. Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration levels.
Interventions
- DRUG Fulvestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2016-03 |
| Est. Completion | 2020-08-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02540330
The ClinicalTrials.gov registry entry for NCT02540330 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atossa Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fulvestrant is the first listed.
NCT02540330 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02540330 about?
NCT02540330 is a clinical study titled "A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant". This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The subsequent 5 subjects of...
What is the current status of trial NCT02540330?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2016-03. Estimated completion is 2020-08-13.
What interventions are being tested in trial NCT02540330?
The interventions under investigation include: Fulvestrant (DRUG).
Who is sponsoring clinical trial NCT02540330?
This trial is sponsored by Atossa Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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