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ATR Kinase Inhibitor
AZD6738 for Myelodysplastic Syndrome
Phase 1
Recruiting
Led By Andrew M Brunner, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with MDS or CMML that has recurred after prior allogeneic stem cell transplantation
Females not breastfeeding and have a negative pregnancy test or evidence of non-child-bearing potential
Must not have
Active CNS involvement of leukemia
Prior allogeneic transplant less than 100 days out from transplant 'day 0' and off systemic immunosuppressive therapy without active grade > 1 GVHD requiring more than 10mg prednisone/day or equivalent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a drug called AZD6738 as a possible treatment for Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia.
Who is the study for?
Adults diagnosed with Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who have not responded to, or cannot tolerate, certain chemotherapy treatments. They should be in a stable condition without acute leukemia and must not have other active cancers. Participants need functioning major organs and agree to use contraception.
What is being tested?
The trial is testing AZD6738, an investigational drug for treating MDS/CMML. It's designed for patients whose disease has progressed after standard therapies or those ineligible for stem cell transplantation. The study will assess the drug's effectiveness and safety.
What are the potential side effects?
Potential side effects of AZD6738 may include blood disorders, fatigue, digestive issues like nausea and vomiting, liver function changes, possible allergic reactions if sensitive to the drug components, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My MDS or CMML has returned after a stem cell transplant.
Select...
I am not pregnant, breastfeeding, and can't become pregnant.
Select...
My MDS or CMML has returned after a stem cell transplant.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My kidney function, measured by creatinine clearance, is sufficient.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My cancer has specific genetic mutations or is wildtype.
Select...
My MDS did not respond to specific chemotherapy, or I couldn't tolerate it.
Select...
My MDS is high-risk and didn't respond to specific chemotherapy treatments.
Select...
I am not eligible for or have chosen not to undergo stem cell transplantation.
Select...
I have been diagnosed with MDS or CMML that is getting worse or not going away.
Select...
I can swallow and keep down pills.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My leukemia has spread to my brain or spinal cord.
Select...
I had a transplant less than 100 days ago and am not on strong immune-suppressing drugs.
Select...
I have been diagnosed with acute myeloid leukemia.
Select...
I have an active hepatitis B or C infection.
Select...
I am HIV-positive.
Select...
I have been diagnosed with ataxia-telangiectasia.
Select...
I have severe, ongoing stomach issues that affect how my body absorbs medication.
Select...
I do not have any uncontrolled illnesses.
Select...
I have previously been treated with ATR or DDR inhibitors.
Select...
I am not taking strong drugs that affect liver enzyme CYP3A4.
Select...
I haven't taken any experimental drugs within the last 21 days or longer.
Select...
I have another cancer that hasn't been treated yet.
Select...
I have not had any heart diseases in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety of AZD6738 in MDS and CMML (Incidence of dose limiting toxicities)
Secondary study objectives
Classification of Toxicity
Overall Response Rate - splicing factor MUT
Overall Response Rate - splicing factor WT
+2 moreOther study objectives
Biomarkers
Factors associated with response/resistance
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: AZD6738Experimental Treatment1 Intervention
Patients will receive AZD6738 orally on a 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceralasertib
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,308 Total Patients Enrolled
47 Trials studying Leukemia
4,805 Patients Enrolled for Leukemia
AstraZenecaIndustry Sponsor
4,400 Previous Clinical Trials
289,122,673 Total Patients Enrolled
43 Trials studying Leukemia
7,263 Patients Enrolled for Leukemia
Andrew M Brunner, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
22 Total Patients Enrolled
1 Trials studying Leukemia
22 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My MDS or CMML has returned after a stem cell transplant.My leukemia has spread to my brain or spinal cord.Your liver function tests should show AST and ALT levels that are not more than 2.5 times the upper limit of normal.My MDS or CMML has returned after a stem cell transplant.I can take care of myself but might not be able to do heavy physical work.I had a transplant less than 100 days ago and am not on strong immune-suppressing drugs.I don't know if I have a splicing factor mutation, but I will test for it before taking the drug.My kidney function, measured by creatinine clearance, is sufficient.I can take care of myself but might not be able to do heavy physical work.My splicing factor mutation test results are available before joining Part 2.My cancer has specific genetic mutations or is wildtype.I agree to use effective birth control during and for 1 week after the study.I have not had major surgery in the last 4 weeks.You are currently participating in another research study.I have not received any live vaccines in the last 4 weeks.My MDS did not respond to specific chemotherapy, or I couldn't tolerate it.I have lower-risk MDS, need regular blood transfusions, and treatments like ESA haven't worked for me.My organ and bone marrow functions are within normal ranges.My MDS is high-risk and didn't respond to specific chemotherapy treatments.I have been diagnosed with acute myeloid leukemia.I am not pregnant, breastfeeding, and can't become pregnant.Your blood clotting levels should not be too high.I have an active hepatitis B or C infection.I am HIV-positive.Your bilirubin levels are normal, unless you have a condition called Gilbert's syndrome, in which case the levels can be slightly elevated but still within a certain range.I haven't had chemotherapy in the last 21 days or five half-lives of the drugs, whichever is longer.I have been diagnosed with ataxia-telangiectasia.I don't have ongoing major side effects from previous treatments.I have severe, ongoing stomach issues that affect how my body absorbs medication.I am 18 years old or older.I do not have any uncontrolled illnesses.I have previously been treated with ATR or DDR inhibitors.I am not taking strong drugs that affect liver enzyme CYP3A4.I have CMML and did not respond well or couldn't tolerate previous HMA chemotherapy.I am not eligible for or have chosen not to undergo stem cell transplantation.I have been diagnosed with MDS or CMML that is getting worse or not going away.I have lower-risk MDS, need regular blood transfusions, and other treatments haven't worked or aren't suitable for me.I have been taking more than 10mg of prednisone or its equivalent daily for up to 14 days before starting the study drug.I have CMML and didn't respond well or couldn't tolerate HMA chemotherapy, or I chose not to receive it.I am 18 years old or older.I haven't taken any experimental drugs within the last 21 days or longer.I have another cancer that hasn't been treated yet.I have not had any heart diseases in the last 6 months.I can swallow and keep down pills.
Research Study Groups:
This trial has the following groups:- Group 1: AZD6738
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.
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