Olaparib for Advanced Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies how well olaparib works in treating patients with glioma, cholangiocarcinoma, or solid tumors with IDH1 or IDH2 mutations that has spread from where it first started (primary site) to other places in the body (metastatic) and that does not respond to treatment (refractory). Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) for specific drugs. If you are taking strong or moderate CYP3A inhibitors or inducers, you will need to stop them 2 to 5 weeks before starting the trial. It's important to discuss your current medications with the trial team to ensure they don't interact with the study drug.
Is Olaparib safe for humans?
Olaparib (Lynparza) has been studied for safety in various cancers, including breast and ovarian cancer. It generally has a manageable safety profile, meaning side effects are present but can be controlled. It has been tested in different populations, including Japanese patients with advanced solid tumors, showing it is generally safe for human use.12345
How is the drug Olaparib unique in treating advanced cancer?
Olaparib is unique because it is a PARP inhibitor (a type of drug that blocks an enzyme involved in repairing damaged DNA) and is used specifically for cancers with BRCA mutations, making it a personalized treatment option. It is taken orally, which can be more convenient compared to some other cancer treatments that require intravenous administration.14567
What data supports the effectiveness of the drug Olaparib (Lynparza) for advanced cancer?
Olaparib (Lynparza) has shown effectiveness in treating ovarian cancer, particularly in patients with BRCA mutations, by helping to shrink tumors and delay disease progression. It is also approved for use in high-risk early breast cancer with similar genetic mutations, indicating its potential effectiveness in other advanced cancers with these mutations.14678
Who Is on the Research Team?
Patricia M Lorusso
Principal Investigator
Yale University Cancer Center LAO
Are You a Good Fit for This Trial?
Adults with advanced glioma, cholangiocarcinoma, or solid tumors that have IDH1/IDH2 mutations and are treatment-resistant can join. They must meet certain health criteria like blood cell counts, organ function tests, agree to use contraception if applicable, and be willing to undergo biopsies. Those with recent major surgery, uncontrolled medical issues, HIV/hepatitis or a history of other cancers may not qualify.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive olaparib orally twice daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
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?
National Cancer Institute (NCI)
Lead Sponsor