Status:
APPROVED_FOR_MARKETING
An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer
Lead Sponsor:
Eisai Inc.
Conditions:
Differentiated Thyroid Cancer
Eligibility:
All Genders
18+ years
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. T...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN (less than or equal to 5 x ULN if subject has liver metastases). If ALP is greater than 3 x ULN (in the absence of liver metastases) or greater than 5 x ULN (in the presence of liver metastases) AND subjects are also known to have bone metastases, the liver-specific ALP must be separated from the total and used to assess the liver function instead of the total ALP
- Provide written informed consent
- Males and females age greater than or equal to 18 years at the time of informed consent
- All females must have a negative serum or urine pregnancy test. Females of childbearing potential and male subjects who are partners of women of childbearing potential must use or their partners must use a highly effective method of contraception
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
June 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02211222
End Date
June 1 2015
Last Update
March 16 2016
Active Locations (13)
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1
La Jolla, California, United States
2
Stanford, California, United States
3
Torrance, California, United States
4
Washington D.C., District of Columbia, United States