Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma
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|ClinicalTrials.gov Identifier: NCT00715013|
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : September 15, 2011
Patupilone trial for patients with recurrent glioblastoma, which are planned for re-operation. Objectives: prolongation of PFS compared to patients with re-operation only, Patupilone tumor concentrations, pharmacokinetic, Perfusion in MRI pre - and post Patupilone. Translational research of tumor tissue exposed to patupilone.
- Trial with medicinal product
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Glioblastoma Planned for Reoperation||Drug: Patupilone||Phase 1 Phase 2|
Prior to and after re-operation patients with recurrent glioblastoma receive the investigational drug Patupilone, a tubulin-inhibitor.
The purpose of the trial is to prolong PFS in this patient population. Patupilone is already used in clinical trials of other tumor entities such as ovarian cancer, breast and lung cancer. Side effects are expected to be manageable.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma Multiforme Prior to and After Secondary Resection: an Open-label Phase I/II Trial.|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
- Drug: Patupilone
- Progression free survival [ Time Frame: 3 years ]
- PFS, OS translational research [ Time Frame: 3 years ]
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): NCT00715013
|Principal Investigator:||Silvia Hofer, MD||UniversitaetsSpital Zuerich|