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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: Completed Phase 2 study, sponsored by Eisai.
NCT03173560 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 343 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (158% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
ORR24W was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) at the Week 24 (after randomization) time point, during treatment or within 28 days after the last dose date but on or prior to the start of new anticancer therapy based on investigator assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nod
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 |
What the finished NCT03173560 record still lists
NCT03173560 is an interventional study that assigns participants to a tested intervention. The registered 343 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (158% higher).
The record links to 0 conditions, and to 2 interventions - of which lenvatinib is the first listed.
NCT03173560 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03173560's enrollment target sits among peer trials
343 136th of 2000 higher than 1,865 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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