Study on the Effectiveness of Olaparib for Patients with Advanced Cancers and Specific Genetic Mutations

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What is this study about?

This clinical trial is focused on studying the effectiveness of a medication called olaparib, also known by its code name AZD-2281, in treating advanced cancers. These cancers are characterized by specific genetic changes, known as mutations, in genes responsible for a process called homologous recombination. Some of these genes include BRCA1, BRCA2, and ATM. The study aims to observe how well olaparib works in patients with these genetic mutations.

Participants in the study will receive olaparib in the form of film-coated tablets, which are taken orally. The study will compare the effects of olaparib on the cancer’s response rate and how long the response lasts. The trial will also monitor the safety of the medication by recording any side effects experienced by participants. The study is designed to last up to 24 months, during which participants will have regular check-ups and assessments to track their progress.

The goal of this research is to better understand how olaparib can help treat advanced cancers with specific genetic mutations. By doing so, it hopes to provide more effective treatment options for patients with these types of cancers. The study will also explore how the medication’s effectiveness relates to specific genetic changes in the tumors, providing valuable insights into personalized cancer treatment.

1 joining the study

Upon joining the study, you will be required to provide informed consent. This means you agree to participate after understanding the details and potential risks of the study.

You must be willing and able to follow the study protocol, which includes attending scheduled visits and undergoing examinations.

2 initial assessment

An initial assessment will be conducted to ensure you meet the study criteria. This includes having at least one lesion that can be accurately assessed using a CT scan.

A sample of your tumor, preserved in a specific way, must be available for genetic testing.

3 eligibility confirmation

You must be over 18 years old and have a confirmed diagnosis of advanced cancer with specific genetic alterations.

Your organ and bone marrow function will be tested to ensure they are normal, and you must have a life expectancy of at least 16 weeks.

4 treatment initiation

If eligible, you will begin treatment with olaparib, which is taken orally in the form of film-coated tablets.

The dosage will be either 100 mg or 150 mg, as determined by the study team, and you will take the medication as directed.

5 ongoing monitoring

Throughout the study, your response to the treatment will be monitored. This includes measuring the response rate and response duration of your cancer to the medication.

Regular assessments will be conducted to ensure your safety and to report any adverse events.

6 completion of study

The study is expected to continue until December 31, 2025, but your participation may end earlier depending on your response to the treatment.

Upon completion, the study team will discuss the results with you and provide any necessary follow-up care.

Who Can Join the Study?

Provide informed consent before any study-specific procedures.
Be willing and able to follow the study rules, including treatment, visits, and exams.
Have at least one tumor that can be measured by a CT scan and checked multiple times.
A sample of the tumor, preserved in a special way, must be available for genetic testing.
Be a female or male aged over 18 years.
Have advanced cancer with a specific genetic change, except for certain breast, prostate, or ovarian cancers.
No approved targeted therapy available for the specific genetic change in the tumor type.
No other clinical trial available for the specific genetic change in the tumor type.
Have normal organ and bone marrow function, checked within 28 days before starting the study treatment.
Have an ECOG performance status of 0-1, which means being fully active or having some symptoms but nearly fully active.
Have a life expectancy of at least 16 weeks.
For women who can have children, be postmenopausal or have a negative pregnancy test within 28 days before starting the study treatment and confirmed on the first day of treatment.

Who Cannot Join the Study?

Patients who do not have a germline mutation or a somatic tumor mutation in specific genes cannot participate. These genes include BRCA1/2, ATM, and others. A germline mutation is a genetic change that is present in every cell of the body and can be passed to children. A somatic tumor mutation is a genetic change that occurs in a tumor and is not inherited.
Patients who do not have a mutation in genes that cause HRD (Homologous Recombination Deficiency) are excluded. HRD is a condition where cells are unable to repair DNA damage properly.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age categories.
Patients who are part of a vulnerable population are not eligible. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Vrije Universiteit Brussel	Jette	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.09.2018

Trial locations

Investigated drugs:

Olaparib

Olaparib is a medication used in this clinical trial to treat advanced cancers in patients who have specific genetic mutations. These mutations are in genes that are involved in repairing damaged DNA. Olaparib works by blocking a protein that helps cancer cells repair their DNA, which can lead to the death of these cancer cells. This medication is being tested to see how well it can shrink tumors and how long it can keep the cancer from getting worse in patients with these genetic mutations.

Advanced Cancer with Homologous Recombination Deficiency (HRD) – This condition involves a group of cancers characterized by the inability of cells to repair DNA damage through the homologous recombination repair pathway. It often occurs due to mutations in specific genes such as BRCA1, BRCA2, and others involved in DNA repair. As the disease progresses, the accumulation of DNA damage can lead to uncontrolled cell growth and tumor development. Patients with HRD-related cancers may experience a variety of symptoms depending on the location and type of cancer. The progression of these cancers can vary widely, with some growing slowly and others more rapidly. Understanding the genetic mutations involved is crucial for studying the disease’s behavior and potential responses to treatment.

Trial ID:

2024-518522-32-00

Protocol code:

BSMO 1-2018

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Olaparib for Patients with Advanced Cancers and Specific Genetic Mutations

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?