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NCT02567409 · ClinicalTrials.gov registry record · Phase 2

Cisplatin and Gemcitabine Hydrochloride With or Without Berzosertib in Treating Patients With Metastatic Urothelial Cancer

A Phase 2 study of Metastatic Bladder Urothelial Carcinoma and Metastatic Ureter Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
87
Enrollment target
20
Study locations

NCT02567409 is a Phase 2 study of Metastatic Bladder Urothelial Carcinoma and Metastatic Ureter Urothelial Carcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 87 participants, below the 119-participant average among 13 other Metastatic Bladder Urothelial Carcinoma trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT02567409, a Phase 2 study of Metastatic Bladder Urothelial Carcinoma and Metastatic Ureter Urothelial Carcinoma, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
87 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial studies how well cisplatin and gemcitabine hydrochloride with or without berzosertib works in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin and gemcitabine hydrochloride work better alone or with berzosertib in treating patients with urothelial cancer.

Interventions

  • DRUG Cisplatin
  • DRUG Gemcitabine Hydrochloride
  • DRUG Berzosertib

Study Locations (20)

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • USC Norris Oncology/Hematology-Newport Beach - Newport Beach
  • Stanford Cancer Institute Palo Alto - Palo Alto
  • Keck Medical Center of USC Pasadena - Pasadena
  • University of California Davis Comprehensive Cancer Center - Sacramento

Massachusetts

  • Massachusetts General Hospital Cancer Center - Boston
  • Brigham and Women's Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston
  • Dana-Farber Cancer Institute - Boston

Arizona

  • Mayo Clinic Hospital in Arizona - Phoenix
  • Mayo Clinic in Arizona - Scottsdale

Kansas

  • University of Kansas Clinical Research Center - Fairway
  • University of Kansas Hospital-Westwood Cancer Center - Westwood

Colorado

  • UCHealth University of Colorado Hospital - Aurora

Florida

  • Mayo Clinic in Florida - Jacksonville

Georgia

  • Emory University Hospital/Winship Cancer Institute - Atlanta

Kentucky

  • University of Kentucky/Markey Cancer Center - Lexington

Trial Details

FieldValue
Enrollment Target 87 participants
Start Date 2017-01-31
Est. Completion 2023-04-25
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT02567409

The ClinicalTrials.gov registry entry for NCT02567409 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 119-participant average among 13 other Metastatic Bladder Urothelial Carcinoma trials with a reported enrollment target (27% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Metastatic Bladder Urothelial Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.

NCT02567409 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Massachusetts, Arizona.

Frequently Asked Questions

What is clinical trial NCT02567409 about?

NCT02567409 is a clinical study titled "Cisplatin and Gemcitabine Hydrochloride With or Without Berzosertib in Treating Patients With Metastatic Urothelial Cancer". This phase II trial studies how well cisplatin and gemcitabine hydrochloride with or without berzosertib works in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in di...

What is the current status of trial NCT02567409?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2017-01-31. Estimated completion is 2023-04-25.

What conditions does trial NCT02567409 study?

This clinical trial studies the following conditions: Metastatic Bladder Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma, Stage IV Bladder Urothelial Carcinoma AJCC v7, Metastatic Renal Pelvis and Ureter Urothelial Carcinoma.

What interventions are being tested in trial NCT02567409?

The interventions under investigation include: Cisplatin (DRUG), Gemcitabine Hydrochloride (DRUG), Berzosertib (DRUG).

Who is sponsoring clinical trial NCT02567409?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02567409 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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