A Phase 2 Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 mg Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile

Official Title

A Multicentre, Randomized, Double-Blind Phase 2 Trial of Lenvatinib (E7080) in Subjects With 131I-Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 mg Daily Will Provide Comparable Efficacy to a 24-mg Starting Dose, But Have a Better Safety Profile

Summary:

This is a multicentre, randomized, double-blind study being conducted as a postmarketing requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has a better safety profile in participants with radioiodine-refractory differentiated thyroid cancer RR-DTC with radiographic evidence of disease progression within the prior 12 months.

Trial Description

Primary Outcome:

  • Objective response rate (ORR)
  • Percentage of treatment-emergent adverse event(s) (TEAEs) with Common Terminology Criteria for Adverse Events (CTCAE) grades of 3 or higher
Secondary Outcome:
  • Progression-free survival (PFS)
  • PFS after next line of treatment (PFS2)
  • Number of participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs)
  • Health-Related Quality of Life (HRQoL)
  • Area under the concentration-time curve (AUC) of lenvatinib
  • Time to treatment discontinuation due to an AE
  • Number of dose reductions
  • Time to first dose reduction
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 tumour assessments or discontinues study treatment if before Week 24. Participants will be randomly assigned to treatment with 1 of 2 blinded dosages of lenvatinib in a 1:1 ratio to receive lenvatinib 18 mg, or 24mg orally once daily (QD). Dose reductions will occur in succession based on the previous dose level (24, 20, 14, 10, and 8 mg QD, or 18, 14, 10, 8, and 4 mg QD, respectively). Once the dose has been reduced, it may not be increased at a later date.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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