Olaparib for Bladder Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial requires a washout period (time without taking certain medications) of 2 weeks for chemotherapy and 4 weeks for monoclonal antibodies before starting the study. Additionally, if you are taking strong or moderate CYP3A inhibitors or inducers, you will need a washout period of 5 half-lives or 3 weeks, whichever is shorter. Please consult with your doctor about your specific medications.
What data supports the effectiveness of the drug Olaparib for bladder cancer?
Olaparib, a drug originally used for ovarian cancer, has shown promise in treating tumors with specific genetic mutations (BRCA1/BRCA2). While direct evidence for bladder cancer is limited, a study suggests that Olaparib may work well in bladder cancer cells, especially when combined with another drug called Metformin.12345
Is Olaparib generally safe for humans?
Olaparib, also known as Lynparza, has been used in various cancer treatments and is generally considered to have a manageable safety profile. Common side effects include nausea, fatigue, and anemia, while more serious effects like myelodysplastic syndrome (a blood disorder) and acute myeloid leukemia (a type of blood cancer) are rare.12678
How is the drug Olaparib unique in treating bladder cancer?
Olaparib is unique because it is a poly (ADP-ribose) polymerase (PARP) inhibitor, which works by targeting cancer cells with BRCA mutations, a mechanism not commonly used in bladder cancer treatments. It is an oral medication, which can be more convenient compared to traditional intravenous chemotherapy.124910
What is the purpose of this trial?
This trial studies how well olaparib works in patients with advanced bladder and other genitourinary cancers that have DNA-repair defects. Olaparib is a drug that stops cancer cells from fixing their damaged DNA, which can help to stop the cancer from growing. The trial targets patients whose cancers have spread and are not responsive to standard treatments.
Research Team
Andrea B Apolo
Principal Investigator
National Cancer Institute LAO
Eligibility Criteria
Adults with advanced bladder cancer or genitourinary tumors that have DNA-repair defects and can't be cured by standard treatments. Participants must have specific genetic changes, provide a tumor sample, not be pregnant or fathering children, and meet certain health criteria like good organ function and blood counts.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive olaparib orally twice daily on days 1-28 of each cycle, with cycles repeating every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 4 weeks, every 2 months for 1 year, then every 3 months thereafter.
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?
National Cancer Institute (NCI)
Lead Sponsor