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Lenvatinib for Advanced Thyroid Cancer

Phase 2

Recruiting

Led By Gregory Randolph, MD

Research Sponsored by Massachusetts Eye and Ear Infirmary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age at the time of informed consent and willing and able to provide written informed consent for the trial

Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1 and no medical contraindication to surgery

Must not have

Gastrointestinal malabsorption or any other condition that might affect the absorption of study drug

Diagnosis of medullary thyroid carcinoma or anaplastic (undifferentiated) thyroid carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is being done to see if lenvatinib is safe and effective in treating patients with a type of thyroid cancer called differentiated thyroid cancer (DTC) that has spread outside of the thyroid gland.

Who is the study for?

This trial is for adults with advanced thyroid cancer who can swallow pills, have controlled blood pressure, and are not pregnant or breastfeeding. They must agree to use effective contraception and cannot have had certain treatments or conditions that would interfere with the study.

What is being tested?

The trial is testing lenvatinib's safety and effectiveness before surgery in patients with invasive extrathyroidal differentiated thyroid cancer. It aims to see if this drug improves surgical outcomes.

What are the potential side effects?

Lenvatinib may cause high blood pressure, fatigue, weight loss, nausea, diarrhea, joint/muscle pain, mouth sores, rash or redness of the skin. Some people might experience bleeding or clotting problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and can sign the consent form.

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I am very active and have no medical reasons preventing surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that affects how my body absorbs medication.

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I have been diagnosed with a specific type of thyroid cancer.

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I have previously been treated with lenvatinib or a similar drug.

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I am not pregnant or breastfeeding.

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I am currently being treated for an infection.

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I have not had a blood clot in the past year.

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My heart's electrical activity is normal, with no significant ECG abnormalities.

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My scans show a tumor inside my airway or surrounding my carotid artery.

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My cancer has spread to my brain or spinal cord.

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I have had radiation therapy to my neck before.

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I do not have serious heart problems like recent heart failure, heart attack, or stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall R0/R1 resection rate

Secondary study objectives

Change in Surgical complexity and morbidity score (SCMS)

Therapeutic procedure

Primary surgery response rate

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LENVATINIBExperimental Treatment1 Intervention

Study procedures include screening for eligibility and study treatment, evaluations, and follow up visits * Lenvatinib will be administered orally daily at a predetermined dose for 2, 4, or 6 cycles, dependent on response. 1 cycle is 28 days. * Surgery per standard of care will follow lenvatinib treatment.

0 / 13Eligibility criteria met