Study of Ceralasertib for Patients with Advanced Cancer with Molecular Changes

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What is this study about?

This clinical trial is focused on studying advanced cancer, specifically in patients whose tumors have certain molecular changes. The treatment being tested is a medication called ceralasertib, which is taken as a film-coated tablet. The purpose of the study is to evaluate how effective this treatment is in managing the disease.

Participants in the study will receive ceralasertib to see how their cancer responds to the treatment. The study will be conducted over a period of time, during which participants will take the medication and attend scheduled visits for monitoring. The study aims to gather information on how well the treatment works in reducing the size of tumors or slowing the progression of the disease.

The trial is designed to provide preliminary insights into the effectiveness of ceralasertib for patients with advanced cancer that has specific molecular alterations. This information will help researchers understand the potential benefits of the treatment and guide future studies. Participants will be closely monitored throughout the study to ensure their safety and to collect data on the treatment’s impact on their cancer.

1 joining the study

Upon joining the study, the participant will be required to provide signed informed consent. This includes agreeing to comply with the study requirements and restrictions.

The participant must be at least 18 years old and able to swallow tablets whole.

2 treatment initiation

The participant will begin treatment with ceralasertib, also known as AZD6738. This medication is administered in the form of a film-coated tablet.

The medication is taken orally. The specific dosage and frequency will be determined by the study protocol and communicated to the participant.

3 treatment duration

The treatment will continue for the duration specified in the study protocol. The participant will be required to attend scheduled visits and undergo examinations as part of the study.

4 monitoring and assessments

Throughout the study, the participant’s response to the treatment will be monitored. This includes assessments of tumor size and other health parameters.

The primary goal is to evaluate the effectiveness of ceralasertib in treating advanced cancer with specific molecular alterations.

5 completion of study

Upon completion of the study, the participant will undergo final assessments to evaluate the overall response to the treatment.

The study is estimated to conclude by February 7, 2025.

Who Can Join the Study?

The participant must have advanced cancer with specific changes in their tumors.
The participant must be able to give informed consent, which means they understand the study and agree to take part.
The participant must provide written consent for optional genetic research, which involves studying their genes.
The participant must be at least 18 years old at the time of signing the consent form.
Participants must use contraception according to local rules if they are of childbearing potential.
The participant must be willing and able to follow the study rules, including attending visits and undergoing treatments.
The participant must be able to swallow tablets whole.

Who Cannot Join the Study?

Patients who do not have advanced cancer with specific changes in their tumor’s genetic material cannot participate.
Patients who are not able to understand or follow the study procedures will be excluded.
Patients who have other serious health conditions that might interfere with the study will not be allowed to join.
Patients who are currently participating in another clinical trial will be excluded.
Patients who have had a recent major surgery or are recovering from one cannot participate.
Patients who are pregnant or breastfeeding will not be allowed to join the study.
Patients who have a history of allergic reactions to similar treatments will be excluded.
Patients who are unable to take oral medications will not be allowed to participate.
Patients who have an active infection that requires treatment will be excluded.
Patients who have a history of drug or alcohol abuse that might affect their ability to participate will not be allowed to join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centr Georges Francois Leclerc	Dijon	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Not recruiting	04.03.2021

Trial locations

Investigated drugs:

Ceralasertib

Ceralasertib is a medication being studied for its potential effectiveness in treating certain types of advanced cancer. It is being tested in patients whose tumors have specific molecular changes, particularly those with alterations in the ATM gene. The goal of using ceralasertib in this trial is to see how well it can help reduce or control the growth of cancer in these patients.

Advanced Cancer Whose Tumours Contain Molecular Alterations – This type of cancer is characterized by the presence of specific genetic changes within the tumor cells. These alterations can affect how the cancer grows and spreads, potentially making it more aggressive. The progression of this disease can vary widely depending on the specific molecular changes present. Tumors with these alterations may not respond well to standard treatments, leading to a need for targeted therapies. The disease can involve various organs and tissues, depending on where the cancer originates and how it spreads. Understanding the molecular profile of the tumor is crucial for determining the most effective treatment approach.

Trial ID:

2024-515102-12-00

Protocol code:

D5339C00001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Ceralasertib for Patients with Advanced Cancer with Molecular Changes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?