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NCT01802970 · ClinicalTrials.gov registry record · Phase 1
Safety and Blood Immune Cell Study of Anakinra Plus Physician's Chemotherapy Choice in Metastatic Breast Cancer Patients
A Phase 1 study, sponsored by Baylor Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01802970: Completed Phase 1 study, sponsored by Baylor Research Institute.
NCT01802970 is a Phase 1 study that has completed, run by Baylor Research Institute. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01802970, a Phase 1 study, has completed, sponsored by Baylor Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
To determine the safety of administering anakinra plus the physician's chemotherapy choice (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with metastatic breast cancer (MBC), as well as determining blood immune cell transcriptional signatures in patients who undergo IL-1 receptor blockade.
Primary Outcome
Patients will receive anakinra plus the physicians chemotherapy choice of nab paclitaxel, or capecitabine, or eribulin, or vinorelbine for metastatic breast cancer. Adverse events will be recorded throughout the trial, and regardless of the severity will be followed up by investigator until resolution is satisfactory. All adverse events and toxicities will be recorded and assessed for 30 days following the last dose of anakinra at a maximum of 6 months. Grading will be done using Common Terminol
Interventions
- DRUG Anakinra plus Standard of Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-12 |
| Est. Completion | 2017-01-04 |
| Phase | Phase 1 |
What the finished NCT01802970 record still lists
NCT01802970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Anakinra plus Standard of Care is the first listed.
NCT01802970 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01802970 about?
NCT01802970 is a clinical study titled "Safety and Blood Immune Cell Study of Anakinra Plus Physician's Chemotherapy Choice in Metastatic Breast Cancer Patients". To determine the safety of administering anakinra plus the physician's chemotherapy choice (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with metastatic breast cancer (MBC), as well as determining blood immune cell transcriptional signatures in patients who undergo IL-1...
What is the current status of trial NCT01802970?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2012-12. Estimated completion is 2017-01-04.
What interventions are being tested in trial NCT01802970?
The interventions under investigation include: Anakinra plus Standard of Care (DRUG).
Who is sponsoring clinical trial NCT01802970?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01802970's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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