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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02686164
The ClinicalTrials.gov registry entry for NCT02686164 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 197-participant average among 20 other Tumors trials with a reported enrollment target (74% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Related
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