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NCT02686164 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study to Determine the Effect of Lenvatinib (E7080) on the Pharmacokinetics of Midazolam in Subjects With Advanced Solid Tumors
A Phase 1 study of Tumors, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 4
- Study locations
NCT02686164: Completed Phase 1 study of Tumors, sponsored by Eisai.
NCT02686164 is a Phase 1 study of Tumors that has completed, run by Eisai. The registered enrollment target is 51 participants, below the 197-participant average among 20 other Tumors trials with a reported enrollment target (74% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02686164, a Phase 1 study of Tumors, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a multicenter, open-label, non-randomized Phase 1 study in participants with advanced solid tumors, excluding hepatocellular carcinoma (HCC), that have progressed after treatment with approved therapies, or for which there are no standard therapies available. The study will also include participants with radioiodine-refractory differentiated thyroid cancer (RR-DTC). Its primary intent is to determine the effect of lenvatinib on CYP3A4 activity as well as to assess the safety and activity of lenvatinib in these participants. The study will be conducted in the following 3 phases: Pretreatment Phase, Treatment Phase, and Extension Phase.
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Lenvatinib
Study Locations (4)
Michigan
- Facility # 1 - Detroit
New York
- Facility # 1 - The Bronx
Pennsylvania
- Facility # 1 - Philadelphia
Texas
- Facility # 1 - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2016-04-18 |
| Est. Completion | 2018-08-16 |
| Phase | Phase 1 |
What the finished NCT02686164 record still lists
NCT02686164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 197-participant average among 20 other Tumors trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Tumors appearing as the primary indexed condition, and to 2 interventions - of which Midazolam is the first listed.
NCT02686164 reports a single indexed study location in Michigan, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02686164 about?
NCT02686164 is a clinical study titled "Phase 1 Study to Determine the Effect of Lenvatinib (E7080) on the Pharmacokinetics of Midazolam in Subjects With Advanced Solid Tumors". This is a multicenter, open-label, non-randomized Phase 1 study in participants with advanced solid tumors, excluding hepatocellular carcinoma (HCC), that have progressed after treatment with approved therapies, or for which there are no standard therapies available. The study will also include part...
What is the current status of trial NCT02686164?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2016-04-18. Estimated completion is 2018-08-16.
What conditions does trial NCT02686164 study?
This clinical trial studies the following conditions: Tumors.
What interventions are being tested in trial NCT02686164?
The interventions under investigation include: Midazolam (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT02686164?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02686164 being conducted?
This trial has 4 study locations across Michigan, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02686164's enrollment target sits among peer trials
51 12th of 20 higher than 9 of 20 other Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tumors 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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