Expanded Access Program With Lenvatinib for the Treatment of Differentiated Thyroid Cancer in Brazil
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03533361 |
Expanded Access Status :
Approved for marketing
First Posted : May 23, 2018
Last Update Posted : December 17, 2018
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Condition or disease | Intervention/treatment |
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Thyroid Cancer | Drug: Lenvatinib |
Study Type : | Expanded Access |
Expanded Access Type : | Individual Patients |
Official Title: | Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer in Brazil |

- Drug: Lenvatinib
Oral capsules: 4 milligrams (mg) and 10 mg

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
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Participants must have histologically or cytologically confirmed diagnosis of one of the following differentiated thyroid cancer subtypes:
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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)
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Follicular thyroid cancer
- Hurthle cell
- Clear cell
- Insular
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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
- Creatinine clearance greater than or equal to 30 milliliters/minute according to the Cockcroft and Gault formula
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Adequate bone marrow function:
- Absolute neutrophil count greater than or equal to 1.5 × 10^9 per Liter (L)
- Hemoglobin greater than or equal to 9.0 grams per deciliter (g/dL) (can be corrected by growth factor or transfusion)
- Platelet count greater than or equal to 100 × 10^9/L
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Adequate liver function:
- Bilirubin less than or equal to 1.5 × 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 × ULN (less than or equal to 5 × ULN if participant has liver metastases). If ALP is greater than 3 × ULN (in the absence of liver metastases) or greater than 5 × ULN (in the presence of liver metastases) and participants 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
- Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before program entry and must agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire program. If currently abstinent, participants must agree to use a double-barrier method as described above if they become sexually active during the program period or for 30 days after lenvatinib discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and must continue to use the same contraceptive during the program and for 30 days after lenvatinib discontinuation.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533361
Brazil | |
Hospital Sirio Libanes | |
Sao Paulo, São Paulo, Brazil, 01246-000 |
Responsible Party: | Eisai Inc. |
ClinicalTrials.gov Identifier: | NCT03533361 |
Other Study ID Numbers: |
E7080-M001-603 |
First Posted: | May 23, 2018 Key Record Dates |
Last Update Posted: | December 17, 2018 |
Last Verified: | May 2018 |
expanded access program radioiodine refractory differentiated lenvatinib |
Thyroid Neoplasms Thyroid Diseases Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Lenvatinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |