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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: Completed Phase 2 study of Metastatic Bladder Urothelial Carcinoma and Metastatic Ureter Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Estimated using the product-limit method of Kaplan and Meier. Event defined as progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2017-01-31 |
| Est. Completion | 2023-04-25 |
| Phase | Phase 2 |
What the finished NCT02567409 record still lists
NCT02567409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 119-participant average among 13 other Metastatic Bladder Urothelial Carcinoma trials with a reported enrollment target (27% lower).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
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Where NCT02567409's enrollment target sits among peer trials
87 4th of 13 higher than 10 of 13 other Metastatic Bladder Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Bladder Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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