TPI 287 in Breast Cancer Metastatic to the Brain
|ClinicalTrials.gov Identifier: NCT01332630|
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : April 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: TPI 287 Drug: Dexamethasone Drug: Benadryl Drug: Ranitidine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open-Label Study of TPI 287 in Patients With Breast Cancer Metastatic to the Brain|
|Actual Study Start Date :||August 16, 2011|
|Actual Primary Completion Date :||April 14, 2017|
|Actual Study Completion Date :||April 14, 2017|
Experimental: TPI 287
TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mgby vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.
Drug: TPI 287
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.
Other Name: DecadronDrug: Benadryl
12.5-25 mg intravenous (IV) push 30-60 minutes prior
Other Name: DiphenhydramineDrug: Ranitidine
As H2 blocker 1mg/kg IV 30-60 minutes prior
- Overall Response Rate (ORR) [ Time Frame: 6 months ]Overall response rate (ORR = Complete Responses plus Partial Responses (CR + PR) where response rates for brain metastases evaluated by MacDonald criteria, and for extracranial disease by standard RECIST, through a combination of radiologic scans and neurological examination and MRI brain scans.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332630
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nuhad K. Ibrahim, MD,BS||M.D. Anderson Cancer Center|