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NCT02702388 · ClinicalTrials.gov registry record · Phase 2
A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile
A Phase 2 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 241
- Enrollment target
NCT02702388: Completed Phase 2 study, sponsored by Eisai.
NCT02702388 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 241 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02702388, a Phase 2 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 241 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind study being conducted as a postmarketing requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has a better safety profile in participants with radioiodine-refractory differentiated thyroid cancer RR-DTC with radiographic evidence of disease progression within the prior 12 months.
Primary Outcome
ORR as of Week 24 was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as of the Week 24 time point or earlier, as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: was at least a 30 percent (%) decrease in sum of diame
Interventions
- DRUG Lenvatinib
- DRUG Lenvatinib matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2017-06-08 |
| Est. Completion | 2020-09-10 |
| Phase | Phase 2 |
What the finished NCT02702388 record still lists
NCT02702388 is an interventional study that assigns participants to a tested intervention. The registered 241 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 (81% higher).
The record links to 0 conditions, and to 2 interventions - of which Lenvatinib is the first listed.
NCT02702388 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02702388 about?
NCT02702388 is a clinical study titled "A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile". This is a multicenter, randomized, double-blind study being conducted as a postmarketing requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has a better safety profile...
What is the current status of trial NCT02702388?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 241 participants. The study started on 2017-06-08. Estimated completion is 2020-09-10.
What interventions are being tested in trial NCT02702388?
The interventions under investigation include: Lenvatinib (DRUG), Lenvatinib matching placebo (DRUG).
Who is sponsoring clinical trial NCT02702388?
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 NCT02702388's enrollment target sits among peer trials
241 239th of 2000 higher than 1,762 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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