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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall R0/R1 resection rate

Secondary outcome measures

Change in Surgical complexity and morbidity score (SCMS)

Therapeutic procedure

Primary surgery response rate

+3 more

Side effects data

From 2022 Phase 2 trial • 3 Patients • NCT03008369

100%

Fatigue

100%

Anorexia

100%

Proteinuria

67%

Hyperthyroidism

67%

Hypertension

67%

Nausea

67%

Diarrhea

67%

Dry skin

33%

Hypothyroidism

33%

Gastrointestinal disorders - Oth spec

33%

Vomiting

33%

Gastroesophageal reflux disease

33%

Mucositis oral

33%

Aspartate aminotransferase increased

33%

Lymphocyte count decreased

33%

Weight loss

33%

Arthralgia

33%

Musculoskeletal, conn tissue - Oth spec

33%

Anxiety

33%

Palmar-plantar erythrodysesthesia syndrm

33%

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Lenvatinib)

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eisai Inc.Industry Sponsor

516 Previous Clinical Trials

159,006 Total Patients Enrolled

Massachusetts Eye and Ear InfirmaryLead Sponsor

106 Previous Clinical Trials

12,919 Total Patients Enrolled

Gregory Randolph, MDPrincipal InvestigatorMassachusetts Eye and Ear Infirmary (MEEI)

Media Library

Thyroid Cancer Research Study Groups: LENVATINIB

Thyroid Cancer Clinical Trial 2023: LENVATINIB Highlights & Side Effects. Trial Name: NCT04321954 — Phase 2

LENVATINIB 2023 Treatment Timeline for Medical Study. Trial Name: NCT04321954 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does LENVATINIB compare to other drugs in its class?

"Out of the 32 LENVATINIB trials currently in Phase 3, 155 are active. Many of these studies take place in Iowa City, but there are 5027 other locations across the globe where research is being conducted."

Answered by AI

How many people are being included in this research project?

"Yes. The clinical trial is still recruiting patients, as noted on the website clinicaltrials.gov. This particular study was posted on March 9th, 2021 and updated February 3rd, 2022. They are enrolling a total of 30 participants at 1 location."

Answered by AI

Are we still able to enroll new patients in this experiment?

"That is correct, the clinical trial mentioned is recruiting patients as of now. The study was originally posted on March 9th 2021 and was last edited on February 3rd 2022. They are searching for 30 patients at 1 site."

Answered by AI

When was LENVATINIB cleared by the FDA?

"LENVATINIB's safety is based on Phase 2 trial data, which only provides evidence of its safety and not efficacy. Our team at Power gave it a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lenvatinib in Locally Advanced Invasive Thyroid Cancer

Gregory Randolph, MD 2021. "Lenvatinib in Locally Advanced Invasive Thyroid Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04321954.

All > Thyroid Cancer > Thyroid