Regorafenib in Relapsed Glioblastoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 112
Summary
- Conditions
- Glioblastoma Multiforme
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The primary aim of the study is to evaluate the overall survival (OS) in the intention to treat (ITT) population. Secondary aims are to evaluate the progression free survival (PFS), safety, objective response rate (ORR), disease control rate (DCR) in the ITT population, and the evaluation of quality...
The primary aim of the study is to evaluate the overall survival (OS) in the intention to treat (ITT) population. Secondary aims are to evaluate the progression free survival (PFS), safety, objective response rate (ORR), disease control rate (DCR) in the ITT population, and the evaluation of quality of life (QoL). Additional exploratory objectives include the analysis of antiangiogenic and metabolic biomarkers in tissue at first and second surgery (if performed) by the evaluation of certain metabolic features of tumors that could be involved in tumor responses to antiangiogenic drugs.
Tracking Information
- NCT #
- NCT02926222
- Collaborators
- BAYER S.p.A. - Italia
- Investigators
- Principal Investigator: Vittorina Zagonel, MD Istituto Oncologico Veneto IRCCS
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