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Ph II Olaparib in Patients w/ Metastatic/Advanced Urothelial Carcinoma w/ DNA-Repair Defects

UCI Specialty Area: Cancer
Principal Investigator: Arash Rezazadeh Kalebasty
Official Title: A Phase II Study of Olaparib (AZD2281) in Patients with Metastatic/Advanced Urothelial Carcinoma and Other Genitourinary Tumors with DNA-Repair Defects
A Study On:
Kidney
Urinary Bladder

Study Description

This phase II trial studies how well olaparib works in treating patients with urothelial cancer 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.

Eligibility

  • Patients must have a histologically confirmed diagnosis of urothelial carcinoma (cancer) of the urothelial tract/bladder cancer.
  • Patients must be able to tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of olaparib.
  • Patients must provide tumor sample for mutation analysis or be willing to undergo mandatory screening biopsy.
  • Patients who have had prior treatment with olaparib or any other PARPi
  • 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 active hepatitis (i.e., Heptatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
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Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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