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NCT01493310 · ClinicalTrials.gov registry record · Phase 1
Nab-paclitaxel (Abraxane) With or Without Mifepristone in Patients With Advanced Breast Cancer
A Phase 1 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01493310: Completed Phase 1 study, sponsored by University of Chicago.
NCT01493310 is a Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01493310, a Phase 1 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This trial will find the best dose of mifepristone when given together with nab-paclitaxel (Abraxane) based on the side effects of the two drugs in patients with advanced breast cancer. Patients will be randomized to receive nab-paclitaxel with or without mifepristone during the first treatment cycle. After the first cycle, all patients will receive nab-paclitaxel with mifepristone until their disease worsens or they experience an unacceptable side effect. This study will test up to 4 doses of mifepristone in combination with nab-paclitaxel. The study will first test the lowest dose in a small group of patients and if they do not have bad side effects, higher doses will be tested.
Primary Outcome
This study will seek the safest dose of mifepristone given in combination with nab-paclitaxel. Safety of each dose will be determined by the number and seriousness of side effects experienced by patients receiving each dose.
Interventions
- DRUG placebo
- DRUG nab-paclitaxel
- DRUG mifepristone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-11 |
| Est. Completion | 2018-05 |
| Phase | Phase 1 |
What the finished NCT01493310 record still lists
NCT01493310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01493310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01493310 about?
NCT01493310 is a clinical study titled "Nab-paclitaxel (Abraxane) With or Without Mifepristone in Patients With Advanced Breast Cancer". This trial will find the best dose of mifepristone when given together with nab-paclitaxel (Abraxane) based on the side effects of the two drugs in patients with advanced breast cancer. Patients will be randomized to receive nab-paclitaxel with or without mifepristone during the first treatment cyc...
What is the current status of trial NCT01493310?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2011-11. Estimated completion is 2018-05.
What interventions are being tested in trial NCT01493310?
The interventions under investigation include: placebo (DRUG), nab-paclitaxel (DRUG), mifepristone (DRUG).
Who is sponsoring clinical trial NCT01493310?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01493310's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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