Your session is about to expire
← Back to Search
ATM Kinase Inhibitor
AZD1390 + SBRT for Metastatic Cancer
Phase 1
Recruiting
Led By Daniel Higginson, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is studying a new treatment for metastatic solid tumor cancer, combining AZD1390 with radiation.
Who is the study for?
Adults with confirmed metastatic solid tumor cancer, suitable for SBRT treatment to two disease sites, and meeting specific health criteria (e.g., adequate blood counts, liver function). Must not be pregnant or breastfeeding and willing to use contraception. Excludes those with severe medical conditions, brain metastases treatments ongoing, recent heart issues, certain lung diseases, high risk of heart rhythm problems.Check my eligibility
What is being tested?
The trial is testing the safety of a new drug called AZD1390 when given alongside Stereotactic Body Radiotherapy (SBRT) in adults with various types of advanced cancers that have spread to other parts of the body.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions from radiotherapy like skin irritation or fatigue and any common drug-related effects such as nausea or allergic reactions. Specific side effects will depend on individual patient responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess participants for toxicities related to study treatment
Trial Design
8Treatment groups
Experimental Treatment
Group I: Arm B, Dose Level 4Experimental Treatment2 Interventions
Participants have peripheral metastasis with bowel and lung in SBRT treatment planning target
Group II: Arm B, Dose Level 3Experimental Treatment2 Interventions
Participants have peripheral metastasis with bowel and lung in SBRT treatment planning target
Group III: Arm B, Dose Level 2Experimental Treatment2 Interventions
Participants have peripheral metastasis with bowel and lung in SBRT treatment planning target
Group IV: Arm B, Dose Level 1Experimental Treatment2 Interventions
Participants have peripheral metastasis with bowel and lung in SBRT treatment planning target
Group V: Arm A, Dose Level 4Experimental Treatment2 Interventions
Participants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target [PTV]) may be triggered at the initial dose level).
Group VI: Arm A, Dose Level 3Experimental Treatment2 Interventions
Participants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target [PTV]) may be triggered at the initial dose level).
Group VII: Arm A, Dose Level 2Experimental Treatment2 Interventions
Participants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target [PTV]) may be triggered at the initial dose level).
Group VIII: Arm A, Dose Level 1Experimental Treatment2 Interventions
Participants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target [PTV]) may be triggered at the initial dose level).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy
2017
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,844 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,272 Previous Clinical Trials
288,612,621 Total Patients Enrolled
Daniel Higginson, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong CYP3A4 inhibitors or inducers in the last 2 weeks.I have had lung inflammation or damage that needed steroids.My cancer has spread, as shown by scans. A biopsy to confirm this was preferred but not mandatory.I have had serious lung infections.I am eligible for a specific radiation therapy targeting 2 cancer sites.I am allergic to AZD1390 or similar drugs.I have a muscle disease or my muscle enzyme levels have been high twice.I can care for myself but may need occasional help.I haven't had cancer treatment 7 days before or after SBRT, nor immune therapy within 28 days.I haven't had radiotherapy in the same area in the last 3 months.My heart's electrical activity is normal and does not pose a risk for abnormal rhythms.My blood counts, liver and kidney functions, and enzyme levels are within safe ranges.I can swallow and keep down pills.I have completed treatment for brain metastases before joining the study.My spinal cord cancer needing palliative care is longer than 10 cm.I have not had a heart attack in the last 6 months and do not have severe heart problems.I am not on medications that interact with the study drugs.I have a history of epilepsy.I do not have any severe illnesses like very bad lung disease.I am not pregnant, breastfeeding, or planning to become pregnant. I agree to use contraception.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B, Dose Level 4
- Group 2: Arm B, Dose Level 3
- Group 3: Arm A, Dose Level 1
- Group 4: Arm A, Dose Level 2
- Group 5: Arm A, Dose Level 3
- Group 6: Arm A, Dose Level 4
- Group 7: Arm B, Dose Level 1
- Group 8: Arm B, Dose Level 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please elucidate the potential risks of Arm A, Dose Level 1 for participants?
"Considering the fact that this is at Phase 1, which implies a lack of knowledge regarding safety and effectiveness, our team has unanimously rated Arm A with Dose Level 1 as having a score of 1 on our safety scale."
Answered by AI
Is the clinical trial currently recruiting participants?
"According to clinicialtrials.gov, this trial is not currently recruiting volunteers at the present moment; however, it was initially listed on February 1st of 2023 and last updated December 28th 2022. Fortunately, 3129 other studies are seeking patient enrolment right now."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger