Differentiated Thyroid CancerNCT02211222
An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer
A study testing Lenvatinib in people with Differentiated Thyroid Cancer, run by Eisai Inc. at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Differentiated Thyroid Cancer
- What is being tested?
- Lenvatinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 13 sitesUnited States
- Study dates
- Start not givento Jun 2015
- 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
- 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.
Show all 19Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Houston, Texas
Study site
La Jolla, California
Study site
Lansing, Michigan
Study site
Lebanon, New Hampshire
Study site
Neptune City, New Jersey
Study site
Philadelphia, Pennsylvania
Study site
Portland, Oregon
Study site
Stanford, California
Study site
Torrance, California
Study site
Washington D.C., District of Columbia
About this study
Official title: An Open-Label, Randomized, Multicenter, Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer
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.
- Conditions
- Differentiated Thyroid Cancer
- Being tested
- Lenvatinib
- Keywords
- Thyroid Cancer, Radioiodine-Refractory, Differentiated
- 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
Also called E7080
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Primary completionAug 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211222
- Sponsor's protocol ID
- E7080-G000-398
- Status last verified
- Mar 2016
- First submitted
- 5 Aug 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Multicenter, Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT02211222
- Acronym / sponsor ID
- E7080-G000-398
- Conditions
- Differentiated Thyroid Cancer
- Keywords
- Thyroid Cancer, Radioiodine-Refractory, Differentiated
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenvatinibAlso: E7080Lenvatinib 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lenvatinib in people with Differentiated Thyroid Cancer, run by Eisai Inc. at 13 sites in United States.
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 19 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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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?
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 16 Mar 2016.