Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Endometrial Neoplasms

Disease Attributes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Crizotinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Crizotinib 250 MG

Keng-Fu Hsu, PhD

Keng-Fu Hsu, MD., PhD.

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.

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.

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

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

CT scan or MRI will be used to evaluate the response every 2 cycles according to the RECIST 1.1 criteria. The best overall response rate is the proportion of patients in whom a complete response (CR) or partial response (PR) was observed.

CT scan or MRI will be used to evaluate the response according to RECIST 1.1 criteria. Progression-free survival is defined as the time from the time of treatment to disease progression or death from any cause.

Overall survival is defined as defined as the time from the start of treatment to death from any cause.

Chi Mei Medical Hospital

Kaohsiung Medical University

Kaohsiung Veterans General Hospital.

National Cheng-Kung University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer	NCT04030429	Endometrial Can...	Crizotinib 250 ...	20 Years - 75 Years	National Cheng-Kung University Hospital
Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer	NCT04030429	Endometrial Can...	Crizotinib 250 ...	20 Years - 75 Years	National Cheng-Kung University Hospital

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