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NCT03375307 · ClinicalTrials.gov registry record · Phase 2
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 2 study of Stage IV Bladder Cancer AJCC v8 and Stage III Bladder Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 17
- Study locations
NCT03375307 is a Phase 2 study of Stage IV Bladder Cancer AJCC v8 and Stage III Bladder Cancer AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 79-participant average among 7 other Stage IV Bladder Cancer AJCC v8 trials with a reported enrollment target (24% lower). The trial reports 17 study locations across 8 states.
The verdict
NCT03375307, a Phase 2 study of Stage IV Bladder Cancer AJCC v8 and Stage III Bladder Cancer AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 17
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Bone Scan
Study Locations (17)
California
- UC San Diego Health System - Encinitas - Encinitas
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- USC Norris Oncology/Hematology-Newport Beach - Newport Beach
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
- UC San Diego Medical Center - Hillcrest - San Diego
New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
- NYP/Weill Cornell Medical Center - New York
Colorado
- UCHealth University of Colorado Hospital - Aurora
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Maryland
- NCI - Center for Cancer Research - Bethesda
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Texas
- University of Texas Medical Branch - Galveston
Utah
- Huntsman Cancer Institute/University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-11-03 |
| Est. Completion | 2026-12-16 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03375307
The ClinicalTrials.gov registry entry for NCT03375307 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 79-participant average among 7 other Stage IV Bladder Cancer AJCC v8 trials with a reported enrollment target (24% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Stage IV Bladder Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03375307 reports 17 study locations spanning 8 distinct geographic areas - top geographies include California, New York, Colorado.
Frequently Asked Questions
What is clinical trial NCT03375307 about?
NCT03375307 is a clinical study titled "Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes". 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. P...
What is the current status of trial NCT03375307?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2020-11-03. Estimated completion is 2026-12-16.
What conditions does trial NCT03375307 study?
This clinical trial studies the following conditions: Stage IV Bladder Cancer AJCC v8, Stage III Bladder Cancer AJCC v8, Metastatic Bladder Carcinoma, Advanced Bladder Carcinoma, Advanced Genitourinary System Carcinoma.
What interventions are being tested in trial NCT03375307?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Bone Scan (PROCEDURE).
Who is sponsoring clinical trial NCT03375307?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03375307 being conducted?
This trial has 17 study locations across California, Colorado, Kentucky, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Stage IV Bladder Cancer AJCC v8
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Stage III Bladder Cancer AJCC v8
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