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Dose-Escalation Study of TPI 287 + Avastin Followed by Randomized Study of the Same Versus Avastin for Glioblastoma

NCT01933815 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2023-02-22

No results posted yet for this study

Summary

This trial is divided into two parts, a dose-escalation study (phase 1) and a randomized study (phase 2).

The purpose of the dose-escalation study (phase 1) is to determine 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 therapy and temozolomide (TMZ).

The purpose of the randomized study (phase 2) is to determine the safety and efficacy of the phase 1 MTD of TPI 287 in combination with bevacizumab versus bevacizumab alone in subjects who have GBM that has progressed following prior radiation therapy and TMZ.

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

  • J. P. Duic, M.D. · The Long Island Brain Tumor Center at Neurological Surgery, P.C.

  • 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

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

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

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2024-11-30
Completion
2025-05-31

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 NCT01933815 on ClinicalTrials.gov