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An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer

NCT02211222 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2016-03-16

No results posted yet for this study

Summary

This Expanded Access Program (EAP) consists of a Prerandomization Phase and a Randomization Phase. Only subjects with radioiodine-refractory DTC who fulfill the eligibility criteria will be treated. These subjects will be treated until progression of disease or unacceptable toxicity.

Conditions

  • Differentiated Thyroid Cancer

Interventions

DRUG

Lenvatinib

Lenvatinib at starting doses of 24-mg, 20-mg, or 14-mg will be administered as a combination of 10-mg capsules and 4-mg capsules to be taken once a day (QD) (recommended to be taken the same time each day). Subjects will receive one of three starting doses of lenvatinib, 24-mg/day, 20-mg/day, or 14-mg/day. Dose reductions occur in succession based on the previous dose level (24, 20, 14, and 10 mg/day). Any dose reduction below 10 mg/day must be discussed with the sponsor. Once the dose has been reduced, it cannot be increased at a later date.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2015-08-31
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02211222 on ClinicalTrials.gov