Phase I/II Cabazitaxel for Recurrent Malignant Glioma
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|ClinicalTrials.gov Identifier: NCT01740570|
Recruitment Status : Withdrawn
First Posted : December 4, 2012
Last Update Posted : January 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Cancer||Drug: Cabazitaxel||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of Cabazitaxel in Adult Patients With Recurrent Malignant Glioma|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2017|
Cabazitaxel by vein on day 1 of each 3 week cycle.
Phase I: Up to 5 dose levels of cabazitaxel tested. Two (2) dose levels will be given over 60 minutes, and 3 will be given over 30 minutes. First group of participants receive the lowest dose level. Each new group receives a higher dose level of cabazitaxel than the group before it, if no intolerable side effects were seen.
Phase II: Cabazitaxel at the highest dose that was tolerated in Phase I.
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.
Other Name: Jevtana
- Maximum Tolerated Dose (MTD) [ Time Frame: 3 weeks ]The MTD of Cabazitaxel defined as the dose level at which no more than 1 out of 6 subjects experiences DLT. Toxicities graded according to the Common Terminology Criteria for Adverse events (CTCAE) Version 4.0. If multiple toxicities are seen, the presence of DLT should be based on the most severe toxicity experienced.
- Progression Free Survival (PFS) [ Time Frame: 6 months ]The primary endpoint is progression within 6 months. Distributions of time to progression or death (PFS), and time to death estimated using the Kaplan-Meier method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740570
|Principal Investigator:||Vinay K. Puduvalli, MD||UT MD Anderson Cancer Center|