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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 is a Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 9 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01493310
The ClinicalTrials.gov registry entry for NCT01493310 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01493310 reports 0 study locations.
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.
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