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Ceralasertib for Advanced Cancer
Study Summary
This trial is testing the effectiveness, safety, and tolerability of drugs that may help repair DNA damage in people with advanced cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have certain health conditions or a family history that could increase the risk of heart problems or abnormal heart rhythms.You have brain metastases that are causing symptoms or are not well controlled.You have previously received a medication called a telangiectasia and rad3 related protein inhibitor.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.
- Group 1: Cohort A
- Group 2: Cohort B
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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/"
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"
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