A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)

Summary

The primary purpose of the study is to evaluate objective response rate (\[ORR\]: complete response \[CR\] and partial response \[PR\]) by investigator review in participants with anaplastic thyroid cancer (ATC) treated with lenvatinib.

Timeline

Start

2016-07-07

Primary completion

2018-09-26

Completion

2018-09-26

Outcome

Missed primary endpoint

Stopped: “Overall response rate was 3% (only 1 out of 33 participants had confirmed PR).”

paper The study was halted for futility as the minimum ORR threshold of 15% was not met upon interim analysis. PMID 33961488 ↗

Publications

• Wirth LJ, Brose MS, Sherman EJ, Licitra L, Schlumberger M, Sherman SI, Bible KC, Robinson B, Rodien P, Godbert Y, De La Fouchardiere C, Newbold K, Nutting C, Misir S, Xie R, Almonte A, Ye W, Cabanillas ME. Open-Label, Single-Arm, Multicenter, Phase II Trial of Lenvatinib for the Treatment of Patients With Anaplastic Thyroid Cancer. J Clin Oncol. 2021 Jul 20;39(21):2359-2366. doi: 10.1200/JCO.20.03093. Epub 2021 May 7.
• Cabanillas ME, McFadden DG, Durante C. Thyroid cancer. Lancet. 2016 Dec 3;388(10061):2783-2795. doi: 10.1016/S0140-6736(16)30172-6. Epub 2016 May 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenvatinib	Small molecule	24 mg	Oral

Indications