RecruitingPhase 2NCT03375307

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

A Phase II Study of Olaparib (AZD2281) in Patients With Metastatic/Advanced Urothelial Carcinoma and Other Genitourinary Tumors With DNA-Repair Defects

Sponsor

National Cancer Institute (NCI)

Enrollment

60 participants

Start Date

Nov 3, 2020

Study Type

INTERVENTIONAL

Conditions

Advanced Bladder Carcinoma Metastatic Bladder Carcinoma Stage IV Bladder Cancer AJCC v8 Stage III Bladder Cancer AJCC v8 Advanced Genitourinary System Carcinoma Metastatic Genitourinary System Carcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether olaparib — a drug that targets cancer cells with certain DNA-repair gene mutations — can help patients with advanced or metastatic bladder cancer or other urinary tract cancers that carry specific genetic changes, when standard treatments have not worked. **You may be eligible if...** - You have been diagnosed with advanced or metastatic non-prostate urinary or genital tract cancer (such as bladder, kidney, or other genitourinary cancers) - Your tumor has a specific DNA-repair gene mutation (such as BRCA1, BRCA2, ATM, BAP1, or one of many other qualifying genes) identified by genetic testing - You have already received prior standard treatment **You may NOT be eligible if...** - Your cancer is prostate cancer - Your tumor does not have any of the qualifying genetic mutations - Your organ function or overall health does not meet the required levels for the trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood collection

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREBone Scan

Undergo bone scan

PROCEDUREComputed Tomography

Undergo CT or PET/CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGOlaparib

Given PO

PROCEDUREPositron Emission Tomography

Undergo PET/CT

Locations(17)

UC San Diego Health System - Encinitas

Encinitas, California, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

NCI - Center for Cancer Research

Bethesda, Maryland, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

NYP/Weill Cornell Medical Center

New York, New York, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Texas Medical Branch

Galveston, Texas, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT03375307

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