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TPI 287 in Breast Cancer Metastatic to the Brain

NCT01332630 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-09-20

Study results available
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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.

Conditions

Interventions

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.

DRUG

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 mg by vein may be given 30-60 minutes prior to treatment with TPI 287.

DRUG

Benadryl

12.5-25 mg intravenous (IV) push 30-60 minutes prior

DRUG

Ranitidine

As H2 blocker 1mg/kg IV 30-60 minutes prior

Sponsors & Collaborators

  • Cortice Biosciences, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Nuhad K. Ibrahim, MD,BS · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-16
Primary Completion
2017-04-14
Completion
2017-04-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01332630 on ClinicalTrials.gov