Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer

Endometrial Cancer Recurrent Clinical Trial

Official title: Phase II Trial of Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer

Status Recruiting

Clinical Trial Summary

The majority of endometrial cancer patients with disease spread beyond the uterus will progress within 1 year. Platinum-based chemotherapy was used as the first-line treatment in metastatic or advanced endometrial cancer. There is no standard protocol for the second-line option when tumors persist or recur. In vitro and in vivo studies showed Crizotinib, an approved drug for the treatment of ALK-positive non-small cell lung cancer, demonstrated activities in endometrial cancer with c-MET kinase and Sema domain mutations. As a consequence, a phase 2 clinical trial to investigate the efficacy of Crizotinib in endometrial cancer patients with MET mutation is initiated.

Clinical Trial Description

In this phase 2 study, the target population is patients with recurrent or persistent metastatic endometrial cancer. The mutation status of c-MET gene will be tested and only patients with c-MET mutation will be enrolled. After enrollment, Crizotinib 250 mg bid will be used orally. CT scan or MRI will be used to determine the response. Crizotinib will be continued till disease progression. Primary end is objective response rate. The secondary endpoints include progression-free survival, overall survival and safety profiles. ;

Related Conditions & MeSH terms

• Endometrial Cancer Recurrent
• Endometrial Neoplasms

• NCT number: NCT04030429
• Study type: Interventional
• Source: National Cheng-Kung University Hospital
• Contact: Keng-Fu Hsu, PhD
• Phone: +886-6-2353535
• Email: d5580@mail.ncku.edu.tw
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2019
• Completion date: February 2024