A Phase 0 Study of AZD1775 in Recurrent GBM Patients
|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: NCT02207010|
Recruitment Status : Active, not recruiting
First Posted : August 1, 2014
Last Update Posted : January 6, 2017
This study would test how much of the new drug, AZD1775, is present in tumor, blood, and skin after one dose of the drug.
The purpose of the study is not to treat the tumor, but to see if the drug actually gets into the tumor cells. This study does not replace routine cancer treatment.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma GBM||Biological: AZD1775||Early Phase 1|
Patients will be administered one dose of AZD1775 prior to surgical resection of their tumor. There will be 2 portions of this trial, referred to as Part 1 and Part 2. Part 1 will involve a dose escalation strategy where 3 separate doses (100, 200, and 400mg) will be evaluated. Each dose cohort will involve 4 patients. Surgery, with tissue harvest for determination of both tissue drug level and biomarker evaluation, will occur at 8 hrs post drug administration.
Part 2 will determine the potential tumor drug level and PD effects at various time intervals after drug administration of a single select drug dose. Currently, we are planning to use a dose (200 mg) that has been deemed safe when used in combination with cytotoxic therapy. However, if results from Part 1 suggest an alternate dose may be preferable, we will consider using that alternate dose in Part 2. Dosing will be followed by surgical resection at 2-4 hrs and at 22-26 hrs post dose.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 0 Study of AZD1775 in Preoperative Glioblastoma Multiforme (GBM) Patients Scheduled for Resection to Evaluate for Central Nervous System (CNS) Penetration|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||May 2018|
Patients will receive a single dose (either 100 mg, 200 mg or 400 mg) of AZD1775, an oral agent, prior to surgery for resection of GBM
All patients receive a single dose of the oral study drug prior to surgery for resection of GBM.
- Plasma concentration of AZD1775 following single dose of AZD1775 [ Time Frame: at baseline, 2-4, 8-12, and 22-26 hours following single dose of AZD1775 ]Will be summarized using descriptive statistics
- Intratumoral concentration of AZD1775 [ Time Frame: up to day of surgery ]Will be summarized using descriptive statistics
- Degree of CDC2 (Tyr15) phosphorylation in tissue [ Time Frame: at baseline and up to 26 hours post dosing ]Will be summarized using descriptive statistics
- Number of GBM cells in M-phase of cell cycle (PH3) [ Time Frame: at baseline and up to 26 hours post dose AZD1775 ]Will be summarized using descriptive statistics
- Presence of double-strand DNA damage (γH2AX). [ Time Frame: at baseline and up to 26 hours post dose AZD1775 ]Will be summarized using descriptive statistics
- P53 mutation status [ Time Frame: up to time of surgery ]Will be summarized using descriptive statistics
- Presence of checkpoint regulator genes in GBM specimens [ Time Frame: up to time of surgery ]checkpoint regulator genes in GBM specimens
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): NCT02207010
|United States, Arizona|
|Barrow Neurological Institute at St. Joseph's Hospital Medical Center|
|Phoenix, Arizona, United States, 85013|
|Principal Investigator:||Nader Sanai, MD||Barrow Neurological Institute at St.Joseph's Hospital Medical Center|