Regorafenib in Bevacizumab Refractory Recurrent Glioblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04051606|
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : July 8, 2020
The purpose of this study is to determine the safety and tolerability of Regorafenib in patients with recurrent or progressive glioblastoma (GBM) who have progressed on bevacizumab. Regorafenib is FDA approved administered as monotherapy during the study.
22 total patients are expected to participate in this study. Even though a participant may meet all the criteria for participation, it is possible that they will not be enrolled in this study.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Glioblastoma||Drug: Regorafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Regorafenib in Bevacizumab Refractory Recurrent Glioblastoma|
|Actual Study Start Date :||July 31, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
160 mg regorafenib 3 weeks on/ one week off in participants with Avastin refractory Glioblastoma, continued until progression or toxicity. Participants will receive an MRI every 8 weeks.
Regorafenib is a monotherapy during the study, oral administration at 160 mg once daily will be administered for 3 weeks on /1 week off.
- Median overall survival (OS) [ Time Frame: Up to 3 years from start of treatment ]Median overall survival (OS) in patients with recurrent or progressive GBM who have progressed on bevacizumab.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 3 years from start of treatment ]Safety and tolerability of regorafenib by CTCAE version 5.0. Safety and tolerability will be defined by the percent of participants experiencing >= grade 3 AE/SAE
- Objective response rate (ORR) [ Time Frame: Up to 3 years from start of treatment ]ORR by modified RANO criteria. ORR defined by modified RANO criteria . The percentage of patients that have at least 50% reduction in their tumor size in 2 dimensions.
- Progression free survival at 6 months (PFS-6). [ Time Frame: at 6 months from start of treatment ]Survival and absence of progressive disease at 6 months, with progression defined as >25% in the sum of products of the perpendicular diameters of CE lesions; evidence of new lesion(s).
- Median time to progression (TTP) [ Time Frame: Up to 3 years from start of treatment ]Time that takes a median patient to progress defined as >25% in the sum of products of the perpendicular diameters of CE lesions; evidence of new lesion(s).
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): NCT04051606
|Contact: Manmeet Ahluwalia, MD||1-866-223-8100||TaussigResearch@ccf.org|
|Contact: Pamela Lackner||+1 email@example.com|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Manmeet Ahluwalia, MD 866-223-8100 TaussigResearch@ccf.org|
|Principal Investigator: Manmeet Ahluwalia, MD|