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NCT01321554 · ClinicalTrials.gov registry record · Phase 3
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)
A Phase 3 study of Thyroid Cancer, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 392
- Enrollment target
- 20
- Study locations
NCT01321554: Completed Phase 3 study of Thyroid Cancer, sponsored by Eisai.
NCT01321554 is a Phase 3 study of Thyroid Cancer that has completed, run by Eisai. The registered enrollment target is 392 participants, above the 273-participant average among 46 other Thyroid Cancer trials with a reported enrollment target (44% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01321554, a Phase 3 study of Thyroid Cancer, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 392 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with lenvatinib 24 mg by continuous once daily oral dosing versus placebo. The study is conducted in 3 phases: a Prerandomization Phase (screening and baseline period), a Randomization Phase (double-blind treatment period), and an Extension Phase (Optional Open Label (OOL) Lenvatinib Treatment Period and a follow-up period).
Primary Outcome
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression or death (whichever occurred first), as determined by blinded IIR using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for the double-blind treatment period (Randomization Phase). Disease progression per RECIST v1.1 was defined as at least a 20 percent (%) relative increase and 5 millimeter (mm) absolute increase in the sum of diameters of target lesions (taking as refe
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lenvatinib
Study Locations (20)
California
- Facility 1 - La Jolla
- Facility 1 - Los Gatos
- Facility 1 - Mission Viejo
- Facility 1 - Orange
- Facility 2 - Orange
- Facility 1 - Sacramento
- Facility 1 - Torrance
Michigan
- Facility 1 - Boston
- Facility 2 - Boston
- Facility 1 - Detroit
Florida
- Facility 1 - Orlando
- Facility 1 - Weston
Illinois
- Facility 1 - Chicago
- Facility 2 - Chicago
Arkansas
- Facility 1 - Little Rock
Colorado
- Facility 1 - Aurora
District of Columbia
- Facility 1 - Washington D.C.
Indiana
- Facility 1 - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 392 participants |
| Start Date | 2011-03-17 |
| Est. Completion | 2019-03-19 |
| Phase | Phase 3 |
What the finished NCT01321554 record still lists
NCT01321554 is an interventional study that assigns participants to a tested intervention. The registered 392 participants enrollment target is mid-sized for trials with a published cap, above the 273-participant average among 46 other Thyroid Cancer trials with a reported enrollment target (44% higher).
The record links to 1 condition, with Thyroid Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01321554 names 20 study sites across 10 states, led by California, Michigan, Florida.
Frequently Asked Questions
What is clinical trial NCT01321554 about?
NCT01321554 is a clinical study titled "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)". This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with lenvatinib 24 mg by continuous once daily oral dosing versus placebo. The study is conducted in 3 phases: a ...
What is the current status of trial NCT01321554?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 392 participants. The study started on 2011-03-17. Estimated completion is 2019-03-19.
What conditions does trial NCT01321554 study?
This clinical trial studies the following conditions: Thyroid Cancer.
What interventions are being tested in trial NCT01321554?
The interventions under investigation include: Placebo (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT01321554?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01321554 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01321554's enrollment target sits among peer trials
392 7th of 46 higher than 40 of 46 other Thyroid Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Thyroid Cancer 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.
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