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COMPLETED Phase 2

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

NCT02567409 · View on ClinicalTrials.gov ↗

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)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02567409

The ClinicalTrials.gov registry entry for NCT02567409 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02567409 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Massachusetts, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02567409?

The interventions under investigation include: Cisplatin (DRUG), Gemcitabine Hydrochloride (DRUG), Berzosertib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02567409?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial