AZD1390 in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients (NCT05182905) | Clinical Trial Compass
Active β Not RecruitingEarly Phase 1
AZD1390 in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients
United States97 participantsStarted 2022-05-27
Plain-language summary
This is an open-label, single-center Phase 0/1b study that will enroll at least 27 participants with recurrent WHO Grade 4 Glioma requiring re-radiation and approximately 35 participants with newly-diagnosed WHO Grade 4 glioma (nGBM). The trial will be composed of a Phase 0 component (subdivided into Arms A - C), and an expansion Phase 1b. Patients with tumors demonstrating a positive PK response in the Phase 0 component of the study will be eligible to graduate to an expansion phase that combines therapeutic dosing of AZD1390 plus standard-of-care fractionated radiotherapy (RT).
Who can participate
Age range18 Years
SexALL
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Exclusion criteria
β. Current use of coumarin-derived anticoagulant for treatment, prophylaxis or otherwise, that cannot be discontinued prior to surgery. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
β. Pregnancy or lactation.
β. Known allergic reactions to components of the AZD1390.
β. Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis, as determined by the investigator.
β. Known active systemic bacterial infection (requiring intravenous \[IV\] antibiotics or fever \>38.5Β°C at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening of viral infection is not required for enrollment.
β. The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
β. Any of the following cardiac criteria:
β
What they're measuring
1
Phase 0: The relative pharmacokinetics (PK) of AZD1390 in tumor tissue from Grade 4 glioma participants treated with AZD1390
Timeframe: Phase 0 Intraoperative
2
Phase 1b: Examine the rate of 6-month progression-free survival glioma participants with demonstrated PK effect.
Timeframe: From the date of Phase 0 surgery to the date of progression