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Thyroid CancerNCT03533361

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

A study testing Lenvatinib in people with Thyroid Cancer, run by Eisai Inc. at 1 site in Brazil.

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Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
Lenvatinib
Type of treatment
Pill or oral medicine
How many people
Not given
Where
1 siteBrazil
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • 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
Show all 26Show fewer
  • 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
  • Creatinine clearance greater than or equal to 30 milliliters/minute according to the Cockcroft and Gault formula
  • 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
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Sirio Libanes

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

About this study

Official title: Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer in Brazil

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
Being tested
Lenvatinib
Keywords
expanded access program, radioiodine refractory, differentiated, lenvatinib
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenvatinibDrug

    Oral capsules: 4 milligrams (mg) and 10 mg

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT03533361
Sponsor's protocol ID
E7080-M001-603
Status last verified
May 2018
First submitted
10 May 2018
Last updated
17 Dec 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Lenvatinib in people with Thyroid Cancer, run by Eisai Inc. at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03533361.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.

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