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

NCT02211222 | Unknown

• 1 other identifier: E7080-G000-398
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 13

Brief 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

Keywords

Thyroid Cancer; Radioiodine-Refractory; Differentiated

Interventions

Lenvatinib DRUG

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.

Also known as: E7080

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have histologically or cytologically confirmed diagnoses of one of the following DTC subtypes: a. Papillary thyroid cancer (PTC) i. Follicular variant ii. Variants (including but not limited to: tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin's-like, trabecular, tumor with nodular fasciitis-like stroma, Hurthle cell variant of papillary carcinoma, poorly differentiated); b.Follicular thyroid cancer (FTC) i. Hurthle cell ii. Clear cell iii.Insular
• Subjects must be radioiodine-refractory or resistant within 12 months of radioiodine therapy and have one of the following:
• One or more lesions that do not demonstrate iodine uptake on any radioiodine scan
• One or more lesions that have substantially increased in size within 12 months of radioiodine therapy, despite demonstration of radioiodine activity at the time of that treatment by pre- or posttreatment scanning
• Cumulative activity of radioiodine of greater than 600 mCi or 22 gigabecquerels (GBq), with the last dose administered at least 6 months prior to study entry
• Subjects must have received and failed treatment with sorafenib for RR-DTC. This criterion will not apply outside the United States if sorafenib is not commercially available in the country where the subject resides.
• ECOG performance status of 0 to 2
• Blood pressure (BP) less than or equal to 150/90 mmHg at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to Cycle 1 Day 1
• Creatinine clearance greater than or equal to 30 mL/min according to the Cockcroft and Gault formula
• Adequate bone marrow function
• Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L
• Hemoglobin greater than or equal to 9.0 g/dL (can be corrected by growth factor or transfusion)
• Platelet count greater than or equal to 100 x 10\^9/L
• Adequate liver function
• Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome

You may not qualify if:

• Subjects having greater than 1+ proteinuria on urine dipstick at screening testing will undergo 24 h urine collection for quantitative assessment of proteinuria. Subjects with urine protein greater than or equal to 1 g/24 h will be ineligible.
• History of congestive heart failure with New York Heart Association (NYHA) Classification greater than II, unstable angina, myocardial infarction, serious cardiac arrhythmia, or stroke within the past 6 months
• Electrocardiogram (ECG) with QT interval (QTc) interval greater than or equal to 480 msec
• Existing anti-cancer therapy-related toxicities of grade greater than or equal to 2, except alopecia and infertility
• History of intolerance to or progression on prior treatment with lenvatinib that led to the discontinuation of lenvatinib
• Any history of or concomitant medical condition that, in the opinion of the investigator, would compromise subject's ability to safely complete the protocol
• Females who are pregnant (positive B-hCG test) or breastfeeding
• Eligible for any other lenvatinib study that is open for recruitment.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (13)

Unknown Facility

La Jolla, California, United States

Location

Unknown Facility

Stanford, California, United States

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Unknown Facility

Torrance, California, United States

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Unknown Facility

Washington D.C., District of Columbia, United States

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Unknown Facility

Chicago, Illinois, United States

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Unknown Facility

Boston, Massachusetts, United States

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Unknown Facility

Lansing, Michigan, United States

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Unknown Facility

Lebanon, New Hampshire, United States

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Unknown Facility

Neptune City, New Jersey, United States

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Unknown Facility

Cleveland, Ohio, United States

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Unknown Facility

Portland, Oregon, United States

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Unknown Facility

Philadelphia, Pennsylvania, United States

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Unknown Facility

Houston, Texas, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 7, 2014
• Primary Completion: August 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

US (13)