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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.
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

Study 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.

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

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,848 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many study participants are being treated with the experimental medication?

"That is accurate. According to clinicaltrials.gov, this trial was posted on December 1st 2020 and is currently seeking 61 patients from 14 different sites."

Answered by AI

Has Ceralasertib undergone drug approval by the FDA?

"Ceralasertib's safety was estimated to be a 2 because, while there is some data supporting its safety, none of it speaks to the medication's efficacy."

Answered by AI

What are the most similar medical studies to Ceralasertib?

"Ceralasertib was first researched in 2014 at a dedicated facility. Since then, 5 clinical trials have completed with positive results. There are presently 25 active investigations being conducted worldwide - many of which are based out of Indianapolis, Indiana."

Answered by AI

Are we still receiving volunteers for this experiment?

"According to the latest information available on clinicaltrials.gov, this trial is still recruiting patients. The listing was first created on December 1st, 2020 and updated as recently as November 7th, 2022."

Answered by AI

At how many different hospitals is this trial taking place?

"Currently, there are 14 sites enrolling patients for this clinical trial. The locations of these clinics include Indianapolis, Duarte and New Orleans as well other cities. If you are interested in participating, please choose the location nearest to you to reduce travel burden."

Answered by AI

Has a trial like this been conducted before?

"Currently, there are 25 ongoing clinical trials for Ceralasertib in 20 countries and 93 cities. The first study was held in 2014 and sponsored by AstraZeneca. This initial trial had 330 participants and completed both Phase 1 & 2 of drug approval. In the 6 years since the original study, 5 more have been conducted."

Answered by AI

Does this research require participants to be over 30 years old?

"According to the study's requirements for eligibility, any person aged 18-130 years old may enroll."

Answered by AI

What are researchers aiming to find out through this clinical trial?

"The primary objective of this clinical trial, as measured over a period of From Screening (Day -28 to -1) until disease progression or withdrawal of consent (upto approximately 3 years), is Cohort B: Composite response rate by RECIST version 1.1. Additionally, this study will also be measuring secondary outcomes including Cohort B: Proportion of participants with confirmed CTC count conversion from unfavourable to favourable which is defined as Conversion of CTC count is defined as a conversion from unfavourable at baseline (≥ 5/7.5 mL blood) to favourable post-baseline (< 5/"

Answered by AI

How can I enroll myself in this clinical trial?

"This study is looking for 61 individuals who currently suffer from advanced solid tumours. Eligible participants must be between 18-130 years old and meet the following additional requirements: have a histologically confirmed diagnosis of AST (excluding NSCLC) or mCRPC tumour, documented prostate cancer progression while on androgen deprivation or after bilateral orchiectomy, have a deleterious or suspected deleterious ATM mutation in their tumour or blood, normal organ and bone marrow function, no curative treatment options, availability of archival or fresh tumour specimens, previously received and progressed on at least one novel hormonal agent , histologically confirmed"

Answered by AI
~12 spots leftby Apr 2025