Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes (NCT03375307)
A Phase II Study of Olaparib (AZD2281) in Patients With Metastatic/Advanced Urothelial Carcinoma and Other Genitourinary Tumors With DNA-Repair Defects
🩺 Plain-English Summary (8th-Grade Level)
This phase II trial studies how well olaparib works in treating patients with bladder cancer and other genitourinary tumors with deoxyribonucleic acid (DNA)-repair defects that has spread to other places in the body (advanced or metastatic) and usually cannot be cured or controlled with treatment. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (30 items) and avoid the listed exclusions (25 items).
Location: UC San Diego Health System - Encinitas — Encinitas, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients who have had prior treatment with olaparib or any other PARP inhibitor (PARPi)
- Patients with myelodysplastic syndrome/acute myeloid leukemia; or baseline features suggestive of myelodysplastic syndrome or acute myelogenous leukemia on peripheral blood smear or bone marrow biopsy, if clinically indicated
- Persistent toxicities (\>= Common Terminology Criteria for Adverse Events \[CTCAE\] grade 2) with the exception of alopecia or peripheral neuropathy, caused by previous cancer therapy
- Patients who are receiving any other investigational agents. Patients may be on other clinical trials or treatment during screening to determine eligibility
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
- History of allergic reactions attributed to compounds of similar chemical or biologic composition of olaparib
- Patients receiving strong or moderate CYP3A inhibitors or inducers are ineligible. A washout period prior to the first dose of olaparib for patients on CYP3A inhibitors/inducers is 5 half-lives or 3 weeks , whichever is shorter. Medications with limited systemic absorption (e.g., ophthalmic, otic) do not require a washout and are permitted.
- Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference texts such as the Physicians' Desk Reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
- Pregnant women are excluded from this study because olaparib is a PARP inhibitor agent with the potential for teratogenic or abortifacient effects
- Any chronic or concurrent acute liver disease
- History of stroke, transient ischemic attack (TIA), or myocardial infarction, within 6 months prior to enrollment
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (17 Sites)
- UC San Diego Health System - Encinitas — Encinitas, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
- UC San Diego Moores Cancer Center — La Jolla, California
- Los Angeles General Medical Center — Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- USC Norris Oncology/Hematology-Newport Beach — Newport Beach, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- UC San Diego Medical Center - Hillcrest — San Diego, California
- UCHealth University of Colorado Hospital — Aurora, Colorado
- University of Kentucky/Markey Cancer Center — Lexington, Kentucky
- NCI - Center for Cancer Research — Bethesda, Maryland
- Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York
- NYP/Weill Cornell Medical Center — New York, New York
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
- University of Texas Medical Branch — Galveston, Texas
- Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Advanced Bladder Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.