drugset / Trial / NCT00510640

Thyroid Cancer and Sunitinib

NCT00510640 ↗

Phase 2 Completed 71 enrolled University Hospital, Bordeaux Pfizer · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Due to arguments showing that angiogenesis could be involved in progression of metastatic thyroid carcinoma and to objective response during previous studies with sunitinib (an angiogenic oncology drug also known as Sutent), this study, THYSU, is justified to evaluate the efficacy of sunitinib in metastatic thyroid carcinoma. Furthermore, the standard treatment of metastatic thyroid carcinoma when a general treatment is to be prescribed is limited to radioiodine. When radioiodine becomes ineffective, there is no standard treatment despite some use of chemotherapy. The objective of the trial is to determine the objective tumor response rate (efficacy) in patients with locally advanced or metastatic anaplastic, differentiated or medullary thyroid carcinoma treated with sunitinib; a secondary objective is to evaluate the safety of sunitinib in these patients. The THYSU trial is a phase II, French multi-center study. This trial's plan is to enroll 75 patients with locally advanced or metastatic anaplastic, differentiated or medullar thyroid carcinoma.

Timeline

Start
2007-08
Primary completion
2012-03
Completion
2012-03

Outcome

Met primary endpoint

paper The primary end-point was reached with an objective response rate of 22% PMID 28301826 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sunitinib Small molecule 50 mg Oral