An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer
Primary Purpose
Differentiated Thyroid Cancer
Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Lenvatinib
Sponsored by
About this trial
This is an expanded access trial for Differentiated Thyroid Cancer focused on measuring Thyroid Cancer, Radioiodine-Refractory, Differentiated
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02211222
Brief Title
An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer
Official Title
An Open-Label, Randomized, Multicenter, Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Approved for marketing
Study Start Date
undefined (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Differentiated Thyroid Cancer
Keywords
Thyroid Cancer, Radioiodine-Refractory, Differentiated
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
E7080
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Facility Information:
City
La Jolla
State/Province
California
Country
United States
City
Stanford
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Lansing
State/Province
Michigan
Country
United States
City
Lebanon
State/Province
New Hampshire
Country
United States
City
Neptune
State/Province
New Jersey
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer
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