Not recruiting

Study on the Safety and Tolerability of Olaparib in Children and Adolescents with Solid Tumors

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety and tolerability of a medication called olaparib in children and adolescents with solid tumors. Solid tumors are a type of cancer that forms in the body's tissues, such as bones, muscles, or organs. The study aims to understand how well olaparib is tolerated by young patients and to determine the appropriate dose for this age group. Olaparib is taken orally, either as a capsule or a tablet, and is being tested to see if it can be a safe treatment option for these patients.

Participants in this study will receive olaparib, and some may receive a placebo. The study will monitor the effects of the medication over time, including any side effects or changes in the participants' health. The trial will also collect information on how the body processes olaparib, which is known as pharmacokinetics. This information will help researchers understand how the drug behaves in the body and how it might be used to treat solid tumors in children and adolescents.

The study is designed to include children and adolescents who have solid tumors that have returned or are not responding to standard treatments. These tumors may include types like osteosarcoma, rhabdomyosarcoma, and neuroblastoma, among others. The trial will involve regular check-ups and assessments to ensure the safety and well-being of the participants. The ultimate goal is to find a safe and effective treatment option for young patients with these challenging conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes providing a tumor sample and a blood sample for testing. The tumor sample is used to check for specific genetic markers, and the blood sample is used for additional genetic testing if you are 2 years or older.
Step 2
Treatment initiation
Once eligibility is confirmed, the treatment phase begins. The medication used in this study is called olaparib, also known as Lynparza. It is administered orally in the form of film-coated tablets.
The dosage and frequency of olaparib will be determined by the study team based on individual needs and responses. The duration of administration will also be specified by the study team.
Step 3
Regular monitoring
Throughout the study, regular monitoring is conducted to assess safety and effectiveness. This includes checking vital signs, conducting blood tests, and evaluating any side effects or adverse reactions.
Regular imaging tests may be performed to assess the response of the tumor to the treatment.
Step 4
Follow-up assessments
Follow-up assessments are conducted at specified intervals to monitor long-term effects and overall health. These assessments may include additional imaging tests and laboratory evaluations.
The study team will provide specific instructions on the schedule and requirements for these follow-up assessments.
Step 5
Completion of study
Upon completion of the study, a final assessment is conducted to evaluate the overall outcomes and any lasting effects of the treatment.
The study team will provide guidance on any further steps or recommendations based on the results of the study.

Who can join the trial?

6 criteria

Patients must be children or teenagers with solid tumors or primary brain tumors that have come back or do not respond to treatment. These tumors should have a specific genetic issue called HRR deficiency or gene mutation. There should be no standard treatment options available for them.
A sample of the tumor, preserved in a special way called formalin fixed, paraffin embedded (FFPE), must be provided for testing. If the patient is 2 years or older, a blood sample is also needed for genetic testing.
Patients must have a performance score of at least 50 on the Lansky scale (for those 16 years or younger) or the Karnofsky score (for those older than 16). These scores measure the patient's ability to carry out daily activities.
For tumors other than neuroblastoma, patients must have at least one tumor that can be measured and has not been treated with radiation. This tumor should be suitable for repeated assessments.
For neuroblastoma tumors, patients must have a tumor that can be seen on scans or shows activity on specific imaging tests like MIBG or FDG-PET scans.
Patients must have normal function of their organs and bone marrow, as determined by tests done within 28 days before starting the study treatment.

Who cannot join the trial?

8 criteria

Patients who have a type of cancer other than solid tumors cannot participate. Solid tumors are abnormal masses of tissue that usually do not contain liquid areas.
Patients who are not within the specified age range for the study cannot participate. The study is for a specific age group.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have certain medical conditions that might interfere with the study cannot participate.
Patients who are taking other medications that might interfere with the study cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients who have allergies to the study medication or similar medications cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Semmelweis University
Budapest, Hungary

Trial locations

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Investigated drugs

Olaparib is a medication being studied for its safety and how well it works in children with solid tumors. It is a type of treatment known as a PARP inhibitor, which means it helps stop cancer cells from repairing themselves, making it harder for them to survive. This study aims to find out how well children can tolerate this medication and to determine the best dose to use in future treatments.

Olaparib

What is already known about the treatment

Olaparib – Olaparib is administered orally in the form of tablets or capsules. It is currently being studied in clinical trials for its safety, tolerability, and effectiveness in treating pediatric patients with solid tumors. The main therapeutic use of Olaparib is to target and treat various types of solid tumors. At the molecular level, Olaparib works by inhibiting an enzyme called PARP, which helps repair damaged DNA in cells; by blocking this enzyme, it prevents cancer cells from repairing themselves, leading to their death. Olaparib is classified as a PARP inhibitor in pharmacology.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they progress, solid tumors can grow in size and may invade nearby tissues. They can also spread to other parts of the body through the bloodstream or lymphatic system. The progression of solid tumors varies depending on their location, type, and the rate at which the cells are dividing.