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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

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 below

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My MDS or CMML has returned after a stem cell transplant.

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I am not pregnant, breastfeeding, and can't become pregnant.

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My MDS or CMML has returned after a stem cell transplant.

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I can take care of myself but might not be able to do heavy physical work.

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My kidney function, measured by creatinine clearance, is sufficient.

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I can take care of myself but might not be able to do heavy physical work.

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My cancer has specific genetic mutations or is wildtype.

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My MDS did not respond to specific chemotherapy, or I couldn't tolerate it.

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My MDS is high-risk and didn't respond to specific chemotherapy treatments.

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I am not eligible for or have chosen not to undergo stem cell transplantation.

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I have been diagnosed with MDS or CMML that is getting worse or not going away.

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I can swallow and keep down pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My leukemia has spread to my brain or spinal cord.

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I had a transplant less than 100 days ago and am not on strong immune-suppressing drugs.

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I have been diagnosed with acute myeloid leukemia.

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I have an active hepatitis B or C infection.

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I am HIV-positive.

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I have been diagnosed with ataxia-telangiectasia.

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I have severe, ongoing stomach issues that affect how my body absorbs medication.

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I do not have any uncontrolled illnesses.

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I have previously been treated with ATR or DDR inhibitors.

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I am not taking strong drugs that affect liver enzyme CYP3A4.

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I haven't taken any experimental drugs within the last 21 days or longer.

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I have another cancer that hasn't been treated yet.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Other study objectives

Biomarkers

Factors associated with response/resistance

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

0 / 25Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,993 Previous Clinical Trials

13,230,669 Total Patients Enrolled

47 Trials studying Leukemia

4,805 Patients Enrolled for Leukemia

AstraZenecaIndustry Sponsor

4,352 Previous Clinical Trials

288,646,757 Total Patients Enrolled

41 Trials studying Leukemia

7,132 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

AZD6738 (ATR Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03770429 — Phase 1

Leukemia Clinical Trial 2023: AZD6738 Highlights & Side Effects. Trial Name: NCT03770429 — Phase 1

AZD6738 (ATR Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03770429 — Phase 1

~9 spots leftby Sep 2025

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