E7080 : A Multicenter, Randomized, Double-blind Phase 2 Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer (RR-DTC) to Evaluate Whether an Oral Starting Dose of 20 mg or 14 mg Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18-75Age 18-75

Thyroid<br/>CancersCancer LocationThyroid
Cancers

Systemic therapy,Treatment | Head and neckThyroid

Trial Overview Read MoreRead more

This phase II trial is evaluating the most effective dose of an oral study drug (lenvatinib) in patients being treated for Thyroid Cancer.
 

This trial is treating patients with Thyroid Cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Multicenter, Randomized, Double-blind Phase 2 Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer (RR-DTC) to Evaluate Whether an Oral Starting Dose of 20 mg or 14 mg Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile

Commercial Sponsor

Eisai Co., Ltd.

Summary

This study consists of 2 phases, the Prerandomization Phase and the Randomization Phase. The Prerandomization Phase will last no longer than 28 days and will include a Screening Period to establish protocol eligibility and a Baseline Period to confirm eligibility and establish disease characteristics prior to randomization and treatment. The Randomization Phase will consist of a Treatment Period and a Follow-up Period. It will begin at the time of randomization of the first participant and will consist of 28-day blinded study treatment cycles. The End of Study will occur at the end of the Randomization Phase, which is defined as when the last participant enrolled completes the Week 24 tumor assessments or discontinues study treatment if before Week 24. Participants will be randomly assigned to treatment with 1 of 3 blinded dosages of lenvatinib in a 1:1:1 ratio to receive lenvatinib 24 mg, 20 mg, or 14 mg orally QD. Dose reductions will occur in succession based on the previous dose level (24, 20, 14, 10, 8, or 4 mg QD). Once the dose has been reduced, it may not be increased at a later date.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Endocrinology & Diabetes
Prahran
Faeeza Davids
f.davids@alfred.org.au
03 9076 5490

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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