Actively Recruiting
A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
Led by AstraZeneca · Updated on 2025-12-22
180
Participants Needed
12
Research Sites
441 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will test an investigational drug called AZD1390 in combination with radiation therapy for the treatment of brain tumors. This is the first time AZD1390 is being given to patients. This study will test safety, tolerability and PK (how the drug is absorbed, distributed and eliminated) of ascending doses of AZD1390 in combination with distinct regimens of radiation therapy
CONDITIONS
Official Title
A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide a tissue sample from primary or metastatic brain tumor
- Have a Karnofsky Performance Score of 60 or higher
- For Arm A/Japan: Histologically confirmed Glioblastoma Multiforme, including relapsed GBM after low-grade glioma radiation
- Radiological evidence of recurrent or progressive disease per RANO criteria for Arm A
- Completed first-line radiation at least 6 months before study start for Arm A
- Seizures must be well controlled on stable anti-epileptic treatment and willing to use anti-epileptic prophylaxis during study
- For Arm B (closed to recruitment): Histologically confirmed solid tumor with brain lesions on MRI
- Not eligible for stereotactic radiosurgery for brain tumor
- No prior brain radiation to the planned treatment area
- Non-CNS cancer controlled allowing washout before AZD1390 start
- No brain metastases seizures or leptomeningeal disease seizures
- Receiving partial brain radiation for brain metastases in Arm B
- For Arm C: Histologically confirmed primary GBM with unmethylated MGMT promoter
- MGMT status determined by PCR or pyrosequencing
- Underwent IDH1 mutation testing regardless of result
- No uncontrolled seizures after surgery requiring more than 2 anti-epileptic drugs
- Willing to use anti-epileptic prophylaxis during study
- For food effect assessment in Arm A: able to fast overnight and consume a high-fat meal or fast as required
You will not qualify if you...
- Received chemotherapy or investigational drugs within 28 days or certain drugs within 6 weeks before starting treatment in Arms A and C
- Received checkpoint inhibitors or other agents within specified washouts before treatment in Arm B
- History of severe brain injury or stroke
- Not eligible for sequential MRI evaluations
- History of epileptic disorders or seizures unrelated to tumor
- Treatment with strong CYP3A4 inhibitors or inducers within 2 weeks before study drug
- Concurrent seizurogenic medications
- History or evidence of interstitial lung disease, radiation pneumonitis requiring steroids, or active lung disease
- Severe or uncontrolled medical conditions like severe COPD
- Prior pneumotoxic drug treatment with lung toxicity within past year
- History or presence of myopathy or high creatine kinase levels
- Cardiac dysfunction including recent myocardial infarction, heart failure, unstable angina, or arrhythmias
- Severe pulmonary infections or active infections in Japan part
- Unresolved toxicities greater than Grade 1 except alopecia at study start
- Prior ATM inhibitor with concurrent radiation therapy for Arm A and Japan part
- For food effect assessment: diabetes or systemic steroid treatment
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Research Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Research Site
New York, New York, United States, 10065
Actively Recruiting
4
Research Site
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
5
Research Site
Richmond, Virginia, United States, 23298
Actively Recruiting
6
Research Site
Chūōku, Japan, 104-0045
Completed
7
Research Site
Hidaka-shi, Japan, 350-1298
Active, Not Recruiting
8
Research Site
Kyoto, Japan, 606-8507
Active, Not Recruiting
9
Research Site
Cambridge, United Kingdom, CB2 0QQ
Active, Not Recruiting
10
Research Site
Glasgow, United Kingdom, G12 0YN
Completed
11
Research Site
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
12
Research Site
London, United Kingdom, W1T 7HA
Withdrawn
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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