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NCT03173560 · ClinicalTrials.gov registry record · Phase 2
Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma
A Phase 2 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 343
- Enrollment target
NCT03173560 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 343 participants.
The verdict
NCT03173560, a Phase 2 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 343 participants
- Enrollment target
Study Summary
Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective response rate \[ORR\] at 24 weeks \[ORR24W\]) with an improved safety profile compared to lenvatinib 18 mg in combination with everolimus 5 mg (based on treatment-emergent intolerable Grade 2, or any greater than or equal to (\>=) Grade 3 adverse events (AEs) in the first 24 weeks after randomization).
Interventions
- DRUG lenvatinib
- DRUG everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 343 participants |
| Start Date | 2017-08-17 |
| Est. Completion | 2024-06-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03173560
The ClinicalTrials.gov registry entry for NCT03173560 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 343 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which lenvatinib is the first listed.
NCT03173560 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03173560 about?
NCT03173560 is a clinical study titled "Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma". Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective response rate \[ORR\] at 24 we...
What is the current status of trial NCT03173560?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 343 participants. The study started on 2017-08-17. Estimated completion is 2024-06-20.
What interventions are being tested in trial NCT03173560?
The interventions under investigation include: lenvatinib (DRUG), everolimus (DRUG).
Who is sponsoring clinical trial NCT03173560?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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