drugset / Trial / NCT02702388
A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a multicenter, 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.
Timeline
- Start
- 2017-06-08
- Primary completion
- 2019-12-12
- Completion
- 2020-09-10
Outcome
Missed primary endpoint
paper did not demonstrate noninferiority compared to a starting dose of 24 mg/day as assessed by ORRwk24 PMID 34664662 ↗
paper with an odds ratio (18/24 mg) of 0.50 (95% CI 0.26, 0.96). PMID 34664662 ↗
Publications
- Taylor MH, Leboulleux S, Panaseykin Y, Konda B, de La Fouchardiere C, Hughes BGM, Gianoukakis AG, Park YJ, Romanov I, Krzyzanowska MK, Garbinsky D, Sherif B, Pan JJ, Binder TA, Sauter N, Xie R, Brose MS. Health-related quality-of-life analyses from a multicenter, randomized, double-blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg/day. Cancer Med. 2023 Feb;12(4):4332-4342. doi: 10.1002/cam4.5308. Epub 2022 Dec 4.
- Brose MS, Panaseykin Y, Konda B, de la Fouchardiere C, Hughes BGM, Gianoukakis AG, Joo Park Y, Romanov I, Krzyzanowska MK, Leboulleux S, Binder TA, Dutcus C, Xie R, Taylor MH. A Randomized Study of Lenvatinib 18 mg vs 24 mg in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer. J Clin Endocrinol Metab. 2022 Feb 17;107(3):776-787. doi: 10.1210/clinem/dgab731.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 18 mg | Oral |
| Subject | Lenvatinib | Small molecule | 24 mg | Oral |