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Phase I/II Bevacizumab Versus Bevacizumab Plus TPI 287 for Recurrent Glioblastoma

NCT01582152 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-06-05

Study results available
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Summary

The goal of Part I of this clinical research study is to find the highest tolerable dose of TPI 287 that can be given with bevacizumab to patients with glioblastoma. The goal of Part II is to learn if TPI 287 when given with bevacizumab can help to control glioblastoma better than when bevacizumab is given alone. The safety of the drug combination will also be studied.

TPI 287 is similar to a type of chemotherapy drug called a taxane and is designed to block a protein (tubulin) that helps the cancer cells divide. By blocking the tubulin, the drug may be able to cause the cancer cells to shrink or stop growing.

Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.

Conditions

  • Brain Neoplasms
  • Central Nervous System Neoplasms

Interventions

DRUG

TPI287

Phase I Starting Dose: 160 mg/m2 given by vein on Day 1 every three weeks of a 42 Day cycle. Phase II Starting Dose: Maximum Tolerated Dose (MTD) from Phase I.

DRUG

Bevacizumab

Arm A + B: 10 mg/kg by vein every 2 weeks of a 42 day cycle.

Sponsors & Collaborators

  • Cortice Biosciences, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • W K Alfred Yung, MD, BS · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01582152 on ClinicalTrials.gov