At a glance
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A Phase 2 Open-Label Study of TPI 287 in Patients With Breast Cancer Metastatic to the Brain
In Brief
A Phase 2 clinical trial evaluating TPI 287, Dexamethasone, and 2 other interventions for Breast Cancer. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The goal of the first part of this clinical research study is to find the highest tolerable dose of TPI-287 in patients with breast cancer that has spread to the brain. The goal of the second part of this study is to learn if TPI-287 can control breast cancer that has spread to the brain. The safety of this drug will also be studied.
Study Details
Timeline
Interventions
Starting dose Phase I: 160 mg/m2 by vein over 60 minutes on Days 1, 8, and 15 of every 28 day cycle. Starting Dose Phase II: Maximum tolerated dose from Phase I.
6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287.
12.5-25 mg intravenous (IV) push 30-60 minutes prior
As H2 blocker 1mg/kg IV 30-60 minutes prior