drugset / Trial / NCT01493310

Nab-paclitaxel (Abraxane) With or Without Mifepristone in Patients With Advanced Breast Cancer

NCT01493310

Phase 1 Completed 9 enrolled University of Chicago
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2011-11
Primary completion
2018-05
Completion
2018-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Mifepristone Small molecule 300 mg Oral
Subject Mifepristone Small molecule 600 mg Oral
Subject Mifepristone Small molecule 900 mg Oral
Subject Mifepristone Small molecule 1200 mg Oral
Background Paclitaxel Small molecule 80 mg/m2 Intravenous