TPI 287 in Breast Cancer Metastatic to the Brain
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|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: Decadron
12.5-25 mg intravenous (IV) push 30-60 minutes prior
Other Name: Diphenhydramine
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|