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NCT03219333 · ClinicalTrials.gov registry record · Phase 2
A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
A Phase 2 study of Urothelial Cancer and Urinary Bladder Neoplasms, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 219
- Enrollment target
- 20
- Study locations
NCT03219333: Completed Phase 2 study of Urothelial Cancer and Urinary Bladder Neoplasms, sponsored by Astellas Pharma.
NCT03219333 is a Phase 2 study of Urothelial Cancer and Urinary Bladder Neoplasms that has completed, run by Astellas Pharma. The registered enrollment target is 219 participants, below the 566-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03219333, a Phase 2 study of Urothelial Cancer and Urinary Bladder Neoplasms, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 219 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer. This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect. Patients who sign up for this trial must also fall into one of these categories: * Patients have already received treatment with platinum-containing chemotherapy * Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.
Primary Outcome
ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as a \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of di
Conditions Studied
Interventions
- DRUG Enfortumab vedotin
Study Locations (20)
California
- Keck Medical Center / University of Southern California - Los Angeles
- Keck Medical Center / Newport Beach - Newport Beach
- Kaiser Permanente Oakland - Oakland
- Chao Family Comprehensive Cancer Center University of California Irvine - Orange
- University of California Irvine - Newport - Orange
- Kaiser Permanente Roseville - Roseville
- University of California Davis - Sacramento
- Kaiser Permanente Sacramento - Sacramento
- Kaiser Permanente San Francisco - San Francisco
- Kaiser Permanente San Jose - San Jose
- Kaiser Permanente San Leandro - San Leandro
- Kaiser Permanente Santa Clara - Santa Clara
- Kaiser Permanente South San Francisco - South San Francisco
- Kaiser Permanente Medical Center Northern California - Vallejo
- Kaiser Permanente Walnut Creek - Walnut Creek
Arizona
- Arizona Oncology Associates, PC - HAL - Goodyear
- Mayo Clinic Arizona - Phoenix
- Arizona Oncology Associates, PC - HOPE - Tucson
Alaska
- Alaska Urological Institute - Anchorage
Colorado
- Rocky Mountain Cancer Centers - Aurora - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2017-10-08 |
| Est. Completion | 2023-07-28 |
| Phase | Phase 2 |
What the finished NCT03219333 record still lists
NCT03219333 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, below the 566-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (61% lower).
The record links to 7 conditions, with Urothelial Cancer appearing as the primary indexed condition, and to 1 intervention - of which Enfortumab vedotin is the first listed.
NCT03219333 names 20 study sites across 4 states, led by California, Arizona, Alaska.
Frequently Asked Questions
What is clinical trial NCT03219333 about?
NCT03219333 is a clinical study titled "A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer". This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. T...
What is the current status of trial NCT03219333?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 219 participants. The study started on 2017-10-08. Estimated completion is 2023-07-28.
What conditions does trial NCT03219333 study?
This clinical trial studies the following conditions: Urothelial Cancer, Urinary Bladder Neoplasms, Urologic Neoplasms, Carcinoma, Transitional Cell, Ureteral Neoplasms.
What interventions are being tested in trial NCT03219333?
The interventions under investigation include: Enfortumab vedotin (DRUG).
Who is sponsoring clinical trial NCT03219333?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03219333 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03219333's enrollment target sits among peer trials
219 17th of 25 higher than 9 of 25 other Urothelial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Cancer 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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