Expanded Access Program With Lenvatinib for the Treatment of Differentiated Thyroid Cancer in Brazil

NCT03533361 | Unknown

• 1 other identifier: E7080-M001-603
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is an Expanded Access Program to make lenvatinib available to participants with radioiodine-refractory differentiated thyroid cancer in Brazil. Participants who have no other treatment options available, and who, in the opinion and clinical judgment of the treating physician, would benefit from treatment with lenvatinib will be enrolled. This is a multicenter, open-label program consisting of 2 phases: a 28-day pretreatment phase (including screening) and a treatment phase. Treatment will be provided as long as there is a clinical benefit based on tumor assessments performed according to the center's standard of care and the judgment of the participant's treating physician.

Conditions

Thyroid Cancer

Keywords

expanded access program; radioiodine refractory; differentiated; lenvatinib

Interventions

Lenvatinib DRUG

Oral capsules: 4 milligrams (mg) and 10 mg

Eligibility Criteria

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

You may qualify if:

• Participants must have histologically or cytologically confirmed diagnosis of one of the following differentiated thyroid cancer subtypes:
• Papillary thyroid cancer
• Follicular variant
• 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)
• Follicular thyroid cancer
• Hurthle cell
• Clear cell
• Insular
• Participants 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 millicurie or 22 gigabecquerels, with the last dose administered at least 6 months prior to program entry
• Participants must have received and failed treatment with sorafenib or have shown intolerance to sorafenib for radioiodine refractory differentiated thyroid cancer.
• Eastern Cooperative Oncology Group performance status of 0 to 2
• Blood pressure less than or equal to 150/90 millimeters of mercury (mmHg) at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1

You may not qualify if:

• Participants having greater than 1+ proteinuria on urine dipstick at screening testing will undergo 24 hours (h) urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 gram/24 h will be ineligible
• History of congestive heart failure with New York Heart Association Classification greater than II, unstable angina, myocardial infarction, serious cardiac arrhythmia, or stroke within the past 6 months
• Electrocardiogram with QT interval (QTc) greater than or equal to 480 milliseconds
• Existing anticancer 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 treating physician, would compromise participant's ability to safely complete the protocol
• Females who are pregnant (positive beta human chorionic gonadotropin test) or breastfeeding
• Eligible for any other lenvatinib program that is open for recruitment

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Hospital Sirio Libanes

São Paulo, São Paulo, 01246-000, Brazil

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: May 10, 2018
• First Posted: May 23, 2018
• Last Updated: December 17, 2018

Record last verified: 2018-05

Locations

BR (1)