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Phase I/II Cabazitaxel for Recurrent Malignant Glioma

NCT01740570 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2018-01-19

No results posted yet for this study

Summary

The goal of Part 1 of this clinical research study is to find the highest tolerable dose of cabazitaxel that can be given to patients with glioblastoma. The goal of Part 2 is to learn if cabazitaxel can help to control glioblastoma. The safety of the study drug will also be studied in both parts.

Cabazitaxel is designed to interfere with the growth of cancer cells by stopping cell division.

Conditions

Interventions

DRUG

Cabazitaxel

Phase I Starting Dose: Cohort 1A) 25 mg/m2 by vein over 1 hour every 3 weeks. Cohort 1B) 20 mg/m2 by vein over 30 minutes every 3 weeks. Phase II: Maximum tolerated dose from Phase I.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Vinay K. Puduvalli, MD · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-04-30

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Entities

Diseases
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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 NCT01740570 on ClinicalTrials.gov