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Thyroid NeoplasmsPhase 4NCT03573960

A Study to Evaluate the Safety and Efficacy of Lenvatinib in Participants With Refractory Differentiated Thyroid Cancer

A Phase 4 study testing Lenvatinib in people with Thyroid Neoplasms, run by Eisai Pharmaceuticals India Pvt. Ltd at 11 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety of lenvatinib in participants with recurrent, metastatic radio-iodine refractory differentiated thyroid cancer (DTC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Neoplasms
What is being tested?
Lenvatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
11 sitesIndia
Study dates
1 Apr 2018to 4 Sep 2025
Phase
Phase 4
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females who are diagnosed with locally Recurrent or Metastatic, Progressive, Radioiodine Refractory DTC, Lenvatinib naive and able to provide written informed consent.
  • Histologically or cytologically confirmed diagnosis of one of the following DTC subtypes: Papillary thyroid cancer (PTC) (including the follicular variants and other variants), Follicular thyroid cancer (FTC) (including Hurthle cell, Clear cell and Insular subtypes).
  • Measurable disease meeting the following criteria: i) At least 1 lesion >= 1.0 centimeter (cm) in the longest diameter for a non-lymph node or >= 1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI). ii) Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must have shown evidence of PD based on RECIST 1.1 to be deemed a target lesion.
  • Evidence of disease progression within 12 months of screening scan.
  • Require thyroxine suppression therapy and thyroid stimulating hormone (TSH) should not be elevated (TSH should be less than [<] 4.0 milli-international units per liter [mIU/L]).
  • Participant must be radioiodine-refractory or resistant within 12 months of radioiodine therapy and have one of the following:
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  • One or more measurable lesions that do not demonstrate iodine uptake on any radioiodine scan.
  • One or more measurable 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 post-treatment scanning.
  • Cumulative activity of radioiodine of greater than (>) 600 milliecurie (mCi) or 22 gigabecquerels (GBq), with the last dose administered at least 6 months prior to study entry.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Based on following laboratory assessment:
  • Creatinine clearance >= 30 milliliter per minute (mL/min) according to the Cockcroft and Gault formula.
  • Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) less than or equal to (<=) 1.5.
  • Adequate bone marrow function:
  • Absolute neutrophil count (ANC) >=1.5*10^9/liter (L) ii. Hemoglobin >= 9.0 gram per deciliter (g/dL) (can be corrected by growth factor or transfusion) iii. Platelet count >=100 * 10^9/L
  • Adequate liver function:
  • Bilirubin <= 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) <= 3*ULN (<= 5*ULN if participant has liver metastases). If ALP is > 3*ULN (in the absence of liver metastases) or > 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.
  • Urine dipstick proteinuria should be < 2+. If > or equal 2 gram (g) proteinuria is detected with dipstick, a 24-hour period urine test will be performed and the result should be < or equal to 1 g/24 hours to permit the inclusion of the patient in the clinical trial.
  • 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 (example, 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 study period or for 30 days after study drug 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 study and for 30 days after study drug discontinuation.

Who cannot join

  • Anaplastic or medullary carcinoma of the thyroid.
  • Two or more prior vascular endothelial growth factor (VEGF)/vascular endothelial growth factor receptor (VEGFR)-targeted therapies or any ongoing treatment for iodine-131 (131I) refractory DTC other than TSH-suppressive thyroid hormone therapy.
  • Blood pressure (BP) >= 140 millimeter of mercury (mmHg) Systolic and >= 90 mmHg Diastolic at screening with or without antihypertensive medications.
  • Woman who are lactating or pregnant at screening or baseline.
  • Participants who received any anticancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug. (This does not apply to the use of TSH-suppressive thyroid hormone therapy).
  • Gastrointestinal malabsorption or any other condition that in the opinion of the investigator affected the absorption of Lenvatinib.
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  • Participant has history of congestive heart failure with New York Heart Association (NYHA) Classification > II, unstable angina, myocardial infarction, serious cardiac arrhythmia, or stroke within the past 6 months.
  • Electrocardiogram (ECG) with QT interval (QTc) interval >= 450 millisecond (msec). (According to Bazett's formula).
  • Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, or similar agents requiring therapeutic international normalized ration (INR) monitoring. (Treatment with low molecular weight heparin [LMWH] will be allowed).
  • Existing anti-cancer therapy-related toxicities of CTCAE version 4.03 grade >= 2, except alopecia and infertility.
  • Any history of or concomitant medical condition that, in the opinion of the investigator, would compromise participant's ability to safely complete the protocol.
  • Active infection (any infection requiring treatment).
  • Active malignancy (except for differentiated thyroid carcinoma, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months.
  • Epistaxis or active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
  • Known intolerance to Lenvatinib (or any of the excipients).
  • Participants with clinically significant laboratory investigations as per the investigator's judgment.
  • Participation in any interventional clinical study within the past 90 days of enrollment to treatment.
  • Male or female of childbearing potential, unwilling to use adequate methods of contraception throughout the study.
  • Participants whom had major surgery within 3 weeks prior to study entry, or who have not recovered from prior major surgery, or whom have surgery scheduled during the course of the study.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

India11 sites

  • Shetty's Hospital

    Bangalore, Karnataka, 560068

  • All India Institute of Medical Sciences

    Bhubaneswar, Odisha, 751019

  • S. P. Medical College & A. G. Hospitals

    Bikaner, Rajasthan, 334003

  • Tata Memorial Hospital

    Mumbai, 400012

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029

  • Indraprastha Apollo Hospital

    New Delhi, National Capital Territory of Delhi, 110076

  • BL Kapoor Hospital, New Delhi

    New Delhi, 110005

  • Deenanath Mangeshkar Hospital

    Pune, Maharashtra, 411004

  • Indrayani Hospital, Alandi

    Pune, 412105

  • Regional Cancer Centre, RCC, Thiruvananthapuram

    Thiruvananthapuram, Kerala, 695011

  • City Cancer Centre

    Vijayawada, 520002

Other trials in India

About this study

Official title: Prospective Single Arm Post Marketing Phase IV Study to Assess the Safety and Efficacy of Lenvatinib in Subjects With Locally Recurrent or Metastatic, Progressive, Radioiodine Refractory Differentiated Thyroid Cancer

The purpose of this study is to evaluate the safety of lenvatinib in participants with recurrent, metastatic radio-iodine refractory differentiated thyroid cancer (DTC).

Being tested
Lenvatinib
Keywords
Lenvatinib, E7080, Refractory Differentiated Thyroid Cancer
Medical subject headings
Thyroid Neoplasms

What participants receive

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

Study groups in NCT03573960
Study groupRoleWhat they receive
Lenvatinib 24 mgExperimentalParticipants will receive 24 mg (two 10-mg capsules + one 4-mg capsule) orally, once daily with or without food in 28-day cycles until disease progression or until unacceptable toxicity occurs.
Receives: Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Grade 2 or Higher Treatment-emergent Adverse Events

    TEAEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment. Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activity of daily living (ADL), grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL, grade 4: Life-threatening consequences; urgent intervention indicated and grade 5: Death related to AE.

    Measured: Baseline up to Week 24

  2. Number of Dose Reductions

    The number of instances of participants having to reduce the dosage of study drug based on specified toxicities.

    Measured: Baseline up to Week 24

  3. Median Time to First Dose Reduction

    Time to first dose reduction is defined as the time period from the first dose to the first dose reduction. Median time taken for the first dose reduction and 95% confidence interval will be calculated and reported.

    Measured: Baseline up to Week 24

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    ORR at 24 weeks is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR). CR is defined as disappearance of all target and non-target lesions. All lymph nodes must be non-pathological in size (less than [<] 10 millimeter [mm] short axis). PR is defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.

    Measured: Week 24

  2. Progression-free Survival (PFS)

    PFS is defined as the time from enrollment of participant in to study to the first sign of Progressive Disease (PD) or death due to any cause if the participant dies without experiencing PD. Disease progression per response evaluation criteria in solid tumor (RECIST) v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.

    Measured: From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurs first) or up to approximately Week 24

  3. Percentage of Participants with Other TEAEs Below Grade 2

    TEAEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment. The severity of all AEs will be graded according to CTCAE version 4.03 where grade 1: Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.

    Measured: Baseline up to Week 24

Timeline

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

  1. First posted29 Jun 2018
  2. Study start1 Apr 2018
  3. Primary completion4 Sep 2025
  4. Study completion4 Sep 2025

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03573960
Sponsor's protocol ID
E7080-M091-507
Status last verified
Feb 2026
First submitted
19 Jun 2018
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lenvatinib in people with Thyroid Neoplasms, run by Eisai Pharmaceuticals India Pvt. Ltd at 11 sites in India.

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 22 inclusion and 19 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: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in India. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Percentage of Participants with Grade 2 or Higher Treatment-emergent Adverse Events (time frame: Baseline up to Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03573960.

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 6 Mar 2026.

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