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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Hopital Des Enfants	Toulouse	France
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Semmelweis University	Budapest	Hungary
Rigshospitalet	Copenhagen	Denmark
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Afnwimuoah Pyryzwyb Hxopwfdd Dp Moybvfzmx	Marseille	France
Figplnreg Pugk Ly Ievffwnrxldwe Bywhjyebn Dcv Hmeppise Usqgsdcdsejan Lj Pqs	Madrid	Spain
Hnbcbstc Vpow dhwfxekn	Barcelona	Spain
Cglgjd Oeywa Lyjckqs	Lille	France
Inqbtxzk Cvily	Paris	France

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	17.10.2019
France	Not recruiting	17.10.2019
Hungary	Not recruiting	17.10.2019
Italy	Not recruiting	17.10.2019
Spain	Not recruiting	17.10.2019

Trial locations

Investigated drugs:

Olaparib

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.

Investigated diseases:

Neoplasm

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.

Trial ID:

2023-507904-30-00

Protocol code:

D0816C00025

NCT ID:

NCT04236414

Trial Phase:

Human Pharmacology (Phase I) – Other

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

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