Phase 0 Analysis of Ixazomib (MLN9708) in Patients With 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: NCT02630030|
Recruitment Status : Completed
First Posted : December 15, 2015
Results First Posted : March 26, 2021
Last Update Posted : March 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Ixazomib||Early Phase 1|
I. Measurement of tissue concentration of ixazomib (ixazomib citrate) in a glioblastoma after preoperative administration.
II. Measurement of blood and plasma concentration of ixazomib during surgical sampling after preoperative administration.
I. Assessment of the safety of ixazomib after single dose administration in glioblastoma patients undergoing surgery for tissue concentration assessment.
Patients receive ixazomib orally (PO) 3 hours before surgery.
After completion of study, patients are followed up for 30 days and then periodically thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Phase 0 Analysis of Ixazomib (MLN9708) in Patients With Glioblastoma|
|Actual Study Start Date :||March 24, 2016|
|Actual Primary Completion Date :||July 1, 2018|
|Actual Study Completion Date :||September 3, 2020|
Patients receive ixazomib PO 3 hours before surgery.
Other Name: MLN9708
- Concentration of Ixazomib in Tumor Tissue [ Time Frame: At time of surgery, approximately 3 hours ]The relationship between patient's demographic, tumor and drug concentration results will be assessed with Pearson's correlation coefficient and tested with Wald's test. In addition, the mean and standard error of the concentrations will be estimated using a random-effects model to account for the within-patient correlation of the tumor biopsy samples. Given the limited number of observations, a relatively simple covariance matrix (e.g. compound symmetry) will be assumed.
- Number of Patients With Safety and Tolerability of Ixazomib [ Time Frame: At the time of surgery, approximately 3 hours ]Safety was assessed with routine postoperative laboratory, vital sign, neurologic exam, and imaging studies through the day of surgery to staple or suture removal. This data was collected and any adverse events graded and their relationship to ixazomib administration determined.
- Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: Up to 30 days ]The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) was used to stratify any adverse patient response to ixazomib. There were no clinically relevant adverse events as a result of ixazomib administration.
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): NCT02630030
|United States, Georgia|
|Emory University/Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Jeffrey J. Olson, MD||Emory University/Winship Cancer Institute|