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DNA-damage Response Agent

Ceralasertib for Advanced Cancer

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented prostate cancer progression at study entry while on androgen deprivation or after bilateral orchiectomy as assessed by the investigator.
Participants must have a histologically confirmed diagnosis of AST (excluding NSCLC) or mCRPC tumour.
Must not have
Acute myocardial infarction.
Exposure to a small molecule investigational product within 14 days or 5 half-lives.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening (day -28 to day -1) until safety follow-up (30 days after last dose) (upto approximately 3 years)
Awards & highlights

Summary

This trial is testing the effectiveness, safety, and tolerability of drugs that may help repair DNA damage in people with advanced cancer.

Who is the study for?
This trial is for adults with advanced solid tumors containing specific ATM mutations, who have progressed on certain treatments like hormonal agents for prostate cancer. They must have normal organ and bone marrow function, no curative treatment options available, and can't join if they've had recent heart issues, uncontrolled medical conditions or infections.Check my eligibility
What is being tested?
The study tests the effectiveness of Ceralasertib in treating advanced cancers with ATM mutations. It looks at how safe it is and what side effects occur when used alone or combined with other drugs. Participants are selected based on their genetic profile related to these mutations.See study design
What are the potential side effects?
While not explicitly listed in the provided information, DNA-damage response agents like Ceralasertib may cause fatigue, nausea, blood count changes leading to increased infection risk or bleeding problems, liver function abnormalities and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have already tried and your cancer got worse while taking at least one newer type of hormone treatment for prostate cancer, such as abiraterone acetate, apalutamide, or enzalutamide.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
You have brain metastases that are causing symptoms or are not well controlled.
Select...
You have previously received a medication called a telangiectasia and rad3 related protein inhibitor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening (day -28 to day -1) until safety follow-up (30 days after last dose) (upto approximately 3 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (day -28 to day -1) until safety follow-up (30 days after last dose) (upto approximately 3 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort A: Objective response rate (ORR) by response evaluation ceiteria in solid tumours (RECIST) version 1.1
Cohort B: Composite response rate by RECIST version 1.1
Secondary outcome measures
Cohort A and B: Number of participants with serious and non-serious adverse events
Cohort A and Cohort B: Best percentage change in tumour size
Cohort A: Duration of Radiological response (DoR) by RECIST version 1.1
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment1 Intervention
Eligible participants (ATM altered mCRPC), will receive oral dose of Ceralasertib as monotherapy.
Group II: Cohort AExperimental Treatment1 Intervention
Eligible participants (ATM altered AST), will receive oral dose of Ceralasertib as monotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceralasertib
2017
Completed Phase 1
~30

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
DNA-damage response agents, commonly used in the treatment of solid tumors, work by interfering with the DNA repair mechanisms in cancer cells. These agents inhibit the pathways that cancer cells use to repair their DNA, causing an accumulation of DNA damage that ultimately leads to cell death. This mechanism is particularly important for solid tumor patients because their tumors often have high rates of genetic mutations and depend heavily on DNA repair for survival. By targeting these repair pathways, these treatments can selectively kill cancer cells, offering a potentially more effective and less toxic therapeutic option.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,302 Previous Clinical Trials
288,624,545 Total Patients Enrolled

Media Library

Ceralasertib (DNA-damage Response Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04564027 — Phase 2
Solid Tumors Research Study Groups: Cohort A, Cohort B
Solid Tumors Clinical Trial 2023: Ceralasertib Highlights & Side Effects. Trial Name: NCT04564027 — Phase 2
Ceralasertib (DNA-damage Response Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04564027 — Phase 2
~12 spots leftby Jul 2025