Olaparib for Pediatric Cancer
Trial Summary
What is the purpose of this trial?
This trial is testing olaparib, a medication, to see if it is safe for children and teenagers with certain hard-to-treat tumors. These patients have tumors that have come back or haven't responded to other treatments. Olaparib works by stopping cancer cells from fixing themselves, which can help to kill them. Olaparib has been approved for use in various cancers, including ovarian and breast cancer, and has shown promising activity in both adult and pediatric patients.
Do I have to stop taking my current medications for the trial?
The trial requires that you do not use strong or moderate CYP3A inhibitors or inducers while participating. If you are taking these, you may need to stop. The protocol does not specify other medications, but you should discuss with the trial team.
What data supports the idea that Olaparib for Pediatric Cancer is an effective treatment?
The available research shows that Olaparib, also known as Lynparza, is primarily used for treating adult cancers like breast and ovarian cancer, especially in patients with specific genetic mutations. There is no direct data provided on its effectiveness for pediatric cancer. However, its success in treating other cancers, such as ovarian cancer, where it has shown promising results in patients with certain genetic backgrounds, suggests potential for effectiveness in similar genetic conditions. Without specific data on pediatric cancer, it's difficult to make a direct comparison to other treatments for this age group.12345
What safety data exists for Olaparib (Lynparza) treatment?
Olaparib (Lynparza) has been evaluated for safety in various studies. It is generally well tolerated, with most adverse events being mild to moderate. Severe adverse events include fatigue, anemia, and neutropenia. Safety data comes from trials in patients with ovarian cancer, breast cancer, and other solid tumors, including a Phase I study in Japanese patients with advanced solid tumors.13567
Is the drug Olaparib (Lynparza) a promising treatment for pediatric cancer?
Olaparib (Lynparza) is a promising drug because it has shown effectiveness in treating certain types of adult cancers, like breast and ovarian cancer, especially in patients with specific genetic mutations. This suggests it could be valuable for treating other cancers, potentially including pediatric cancer.12346
Research Team
Milenkova Tsveta
Principal Investigator
AstraZeneca
Eligibility Criteria
This trial is for children and adolescents aged 6 months to under 18 with solid tumors that have relapsed or are resistant to treatment. They must be able to swallow tablets, have a tumor sample available for testing, and meet specific genetic criteria indicating a deficiency in HRR (a DNA repair process). Patients who've had certain recent treatments or those with blood disorders like MDS/AML can't participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive olaparib monotherapy with a single dose on Day 1, followed by continuous dosing from Day 2 onwards
Follow-up
Participants are monitored for safety and effectiveness after treatment
Signal Identification
Secondary analysis of response in patients with HRR gene mutations
Treatment Details
Interventions
- Olaparib
Olaparib is already approved in European Union, United States for the following indications:
- Breast cancer
- Ovarian cancer
- Fallopian tube cancer
- Peritoneal cancer
- Pancreatic cancer
- Prostate cancer
- Endometrial cancer
- Ovarian, fallopian tube, and primary peritoneal cancer
- Breast cancer
- Prostate cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology