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NCT03474107 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 608
- Enrollment target
NCT03474107 is a Phase 3 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 608 participants.
The verdict
NCT03474107, a Phase 3 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 608 participants
- Enrollment target
Study Summary
The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy. This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy. In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.
Interventions
- DRUG Docetaxel
- DRUG Enfortumab Vedotin
- DRUG Paclitaxel
- DRUG Vinflunine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2018-06-27 |
| Est. Completion | 2025-11-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03474107
The ClinicalTrials.gov registry entry for NCT03474107 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 608 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.
NCT03474107 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03474107 about?
NCT03474107 is a clinical study titled "A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)". The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy. This study compared progression-free survival on study therapy (PFS1); t...
What is the current status of trial NCT03474107?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 608 participants. The study started on 2018-06-27. Estimated completion is 2025-11-27.
What interventions are being tested in trial NCT03474107?
The interventions under investigation include: Docetaxel (DRUG), Enfortumab Vedotin (DRUG), Paclitaxel (DRUG), Vinflunine (DRUG).
Who is sponsoring clinical trial NCT03474107?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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