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Safety & Efficacy Study of TPI 287 + Avastin in Adults With Glioblastoma That Progressed Following Prior Avastin Therapy

NCT02047214 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2018-01-31

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, maximum tolerated dose (MTD), and efficacy of TPI 287 in combination with Avastin (bevacizumab) in subjects who have glioblastoma multiforme (GBM) that has progressed following prior radiation and temozolomide (TMZ) therapy and that has progressed following prior bevacizumab therapy.

Conditions

Interventions

DRUG

TPI 287

TPI 287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class. TPI 287 is an Investigational Drug.

DRUG

Bevacizumab

Avastin (bevacizumab) is an FDA approved drug indicated for multiple cancers, including as a single agent for GBM for adult patients with progressive disease following prior therapy. Single agent effectiveness is based on improvement in objective response rate; no data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab.

Sponsors & Collaborators

  • Cortice Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Samuel A. Goldlust, M.D. · John Theurer Cancer Center at Hackensack University Medical Center

  • Louis B. Nabors, III, M.D. · University of Alabama at Birmingham

  • Sigmund Hsu, M.D. · Memorial Hermann Hospital

  • Nimish Mohile, M.D. · University of Rochester

  • Solmaz Sahebjam, M.D. · H Lee Moffitt Cancer Center and Research Institute, Inc.

  • Tara L. Benkers, M.D. · Swedish Neuroscience Institute

  • Priya Kumthekar, M.D. · Northwestern University

  • Jian Campian, M.D., Ph.D. · Washington University School of Medicine

  • David Schiff, M.D. · University of Virginia Health System

  • Camilo E. Fadul, M.D., F.A.A.N. · Dartmouth-Hitchcock Medical Center

  • Pierre Giglio, M.D. · Ohio State University

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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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 NCT02047214 on ClinicalTrials.gov