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

Part of paid clinical trials in Encinitas, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03375307
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood collection
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Olaparib — DRUG
    Given PO
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

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.

Key Dates

Start date
Nov 3, 2020
Status verified
Jun 2026
Primary completion
Dec 16, 2026
Completion
Dec 16, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort I (olaparib)
    Patients that have cancer-associated DNA-repair gene mutations receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT, MRI, PET/CT, or bone scan and optional tumor biopsy and bone marrow biopsy on study.
  • Experimental: Cohort II (biospecimen collection)
    Patients that do not have cancer-associated DNA-repair gene mutations undergo blood sample collection at baseline. Additionally, patients undergo CT, MRI, PET/CT, or bone scan and optional tumor biopsy and bone marrow biopsy on study.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to 5 years ]

Locations (17)

FacilityCityStateZIPSite coordinators
UC San Diego Health System - EncinitasEncinitasCalifornia92024-
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
USC Norris Oncology/Hematology-Newport BeachNewport BeachCalifornia92663-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UC San Diego Medical Center - HillcrestSan DiegoCalifornia92103-
UCHealth University of Colorado HospitalAuroraColorado80045-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
NCI - Center for Cancer ResearchBethesdaMaryland20892-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
NYP/Weill Cornell Medical CenterNew YorkNew York10065-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
University of Texas Medical BranchGalvestonTexas77555-0565-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

Find similar trials in Encinitas, CA

By research site
UC San Diego Health System - Encinitas· Encinitas, CAUCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CAUC San Diego Moores Cancer Center· La Jolla, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUSC Norris Oncology/Hematology-Newport Beach· Newport Beach, CA

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