Trial of Ponatinib in Patients With Bevacizumab-Refractory 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02478164|
Recruitment Status : Active, not recruiting
First Posted : June 23, 2015
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Ponatinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Ponatinib in Patients With Bevacizumab-Refractory Glioblastoma|
|Actual Study Start Date :||July 2015|
|Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2018|
Drug will be administered once daily per cycle through oral ingestion.
- 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 ]
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): 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|