Trial of Ponatinib in Patients With Bevacizumab-Refractory Glioblastoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Ponatinib in Patients With Bevacizumab-Refractory Glioblastoma|
- Progression free survival [ Time Frame: 3 months ]
- Radiographic response [ Time Frame: 2 years ]Radiographic response is defined as the proportion of patients with a best overall response of CR or PR divided by the total number of patients enrolled.
- Overall survival [ Time Frame: From date of first dose until the date of death from any cause, assessed for approximately 3 years. ]
- Progression free survival [ Time Frame: From date of first dose until the date of first documented clinical or radiographic evidence of progressive disease, assessed for approximately 2 years. ]Kaplan-Meier method
- Safety Profile as Summarized With Descriptive Statistics (Using Toxicity Data Gathered on Trial) [ Time Frame: 2 years ]
|Actual Study Start Date:||July 2015|
|Estimated Study Completion Date:||July 2018|
|Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Drug will be administered once daily per cycle through oral ingestion.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved Ponatinib for your specific disease but it has been approved for other uses.
Ponatinib is a drug that may stop cancer cells from growing by affecting different kinds of proteins in cancer cells. Glioblastoma cells can be driven by mutated forms of a protein called c-kit (KIT) which are present in glioblastoma cells. Laboratory studies suggest that ponatinib has activity against mutated forms of (KIT) which is important in glioblastoma and therefore suggests that ponatinib may help to control the growth of glioblastoma. In this research study the study team is looking to see if ponatinib is safe and is able to control the growth of glioblastoma in people who have not responded to treatment with bevacizumab.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02478164
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Eudocia Lee, MD||Dana-Farber Cancer Institute|