Ceralasertib for Advanced Cancer

Recruiting at 21 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must not be taking: Strong CYP 3A inhibitors

Disqualifiers: Cardiac diseases, Active infections, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Up to 2 years 4 months

57 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a medication in patients with advanced solid tumors or metastatic prostate cancer. It targets those with specific molecular changes in their tumors. The drug works by stopping cancer cells from repairing their DNA, making it harder for them to survive.

Eligibility Criteria

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.

Inclusion Criteria

Availability of archival or fresh tumour specimens for central testing of ATM protein loss using immunohistochemistry and for confirmation of ATM mutation using next generation sequencing.

Participants must have a deleterious or suspected deleterious ATM mutation in tumour or blood (germline or ctDNA). Definitions of qualifying ATM mutations may include deleterious/suspected deleterious, pathogenic/likely pathogenic, disease- or cancer-associated variants, or equivalent wording. Variants of unknown significance, benign or likely benign alterations are not qualifying.

Documented prostate cancer progression at study entry while on androgen deprivation or after bilateral orchiectomy as assessed by the investigator.

Exclusion Criteria

You have certain health conditions or a family history that could increase the risk of heart problems or abnormal heart rhythms.

Mean resting corrected QT interval (QTc) > 470 msec obtained from three electrocardiograms (ECGs) in 24 hours using the Fredericia formula.

Acute myocardial infarction.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

2 visits (in-person)

Treatment

Participants receive oral dose of Ceralasertib 160 mg twice daily

Up to 2 years 4 months

Regular visits for monitoring and dose adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days post last dose

1 visit (in-person)

Treatment Details

Interventions

• Ceralasertib

Trial Overview 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.

Participant Groups

Group I: Cohort B Experimental Treatment 1 Intervention

Eligible participants (ATM altered mCRPC), will receive oral dose of Ceralasertib as monotherapy.

Group II: Cohort A Experimental Treatment 1 Intervention

Eligible participants (ATM altered AST), will receive oral dose of Ceralasertib as monotherapy.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology