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NCT00784303 · ClinicalTrials.gov registry record · Phase 2

Evaluating the Safety and Efficacy of Oral Lenvatinib in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

A Phase 2 study, sponsored by Eisai.

Completed
Registry status
Phase 2
Development phase
117
Enrollment target

NCT00784303: Completed Phase 2 study, sponsored by Eisai.

NCT00784303 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 117 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00784303, a Phase 2 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 2
Development phase
117 participants
Enrollment target

Study Summary

The purpose of this study is to determine the safety and efficacy of oral lenvatinib in participants with medullary thyroid cancer (MTC) or radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC), unresectable differentiated thyroid cancers, stratified by Histology.

Primary Outcome

ORR was the percentage of participants with best overall response (BOR) of complete response (CR) and partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 for target lesions using magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent imaging review (IIR). CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as

Interventions

  • DRUG Lenvatinib (DTC Cohort)
  • DRUG Lenvatinib (MTC Cohort)

Trial Details

FieldValue
Enrollment Target 117 participants
Start Date 2008-11-06
Est. Completion 2019-03-29
Phase Phase 2
Eisai

287 total trials

What the finished NCT00784303 record still lists

NCT00784303 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower).

The record links to 0 conditions, and to 2 interventions - of which Lenvatinib (DTC Cohort) is the first listed.

NCT00784303 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00784303 about?

NCT00784303 is a clinical study titled "Evaluating the Safety and Efficacy of Oral Lenvatinib in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology". The purpose of this study is to determine the safety and efficacy of oral lenvatinib in participants with medullary thyroid cancer (MTC) or radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC), unresectable differentiated thyroid cancers, stratified by Histology.

What is the current status of trial NCT00784303?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 117 participants. The study started on 2008-11-06. Estimated completion is 2019-03-29.

What interventions are being tested in trial NCT00784303?

The interventions under investigation include: Lenvatinib (DTC Cohort) (DRUG), Lenvatinib (MTC Cohort) (DRUG).

Who is sponsoring clinical trial NCT00784303?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00784303's enrollment target sits among peer trials

117 623rd of 2000 higher than 1,378 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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Source: ClinicalTrials.gov NCT00784303, the US trial registry maintained by the National Library of Medicine. NCT00784303 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.