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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: Recruiting Phase 2 study of Stage IV Bladder Cancer AJCC v8 and Stage III Bladder Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST). ORR will be reported along with 95% exact confidence intervals.

Conditions Studied

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

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

FieldValue
Enrollment Target 60 participants
Start Date 2020-11-03
Est. Completion 2026-12-16
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What NCT03375307 shows while recruiting

NCT03375307 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 79-participant average among 7 other Stage IV Bladder Cancer AJCC v8 trials with a reported enrollment target (24% lower).

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 lists 17 locations in 8 states (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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More recruiting context for NCT03375307

Source: ClinicalTrials.gov NCT03375307, the US trial registry maintained by the National Library of Medicine. NCT03375307 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.