Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma
Public ClinicalTrials.gov record NCT03173560. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-Label (Formerly Double-Blind), Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination With Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03173560
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 343 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 16, 2017
- Primary completion
- Feb 13, 2020
- Completion
- Jun 19, 2024
- Last update posted
- Mar 31, 2025
2017 – 2024
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| Innovative Clinical Research Institute, LLC | Whittier | California | 90603 | — |
| Baptist Health Medical Group Oncology, LLC - US Oncology | Miami | Florida | 33143 | — |
| Optimal Research | Honolulu | Hawaii | 96819 | — |
| Oklahoma Cancer Specialist and Research Institute , LLC | Tulsa | Oklahoma | 74146 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Texas Oncology PA - US Oncology | Fort Worth | Texas | 76104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 85 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03173560, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 31, 2025 · Synced Sep 17, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03173560 live on ClinicalTrials.gov.