Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer
Reason given: Patients were recruited during screen phase but fewer patients met criteria.
Key facts
- Phase
- Phase 2
This trial has no sites in United States.
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Trial details
- Who runs it
- National Cheng-Kung University Hospital
- Trial code
- NCT04030429
- Record updated
- 16 July 2025
- Original description
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.Read full original descriptionShow less
Phase II Trial of Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer
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.
Inclusion: Age no less than 20 years and no more than 75 years, at the time of acquisition of informed consent; Histological confirmed epithelial endometrial cancer; Disease recurrent after curative therapy or adjuvant therapy including surgery, chemotherapy, radiotherapy or hormone therapy; Metastatic/recurrent/persistent endometrial cancer; Tumor tissue with high expression in immunohistochemistry stain (IHC) or somatic c-MET mutation; Patients with symptomatic recurrent lesion or Image diagnosis (including ultrasound, Computed Tomography or Magnetic Resonance Imaging) recurrent status; ECOG Performance status 0-2; At least one distinct tumor, not previous irradiated, measurable lesion according to RECIST (version 1.1); Adequate organ function; Bone marrow:; Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L WBC ≥ 3.0 x 10\^9/L Platelet count ≥ 100 x 10\^9/L Hemoglobin ≥ 9 g/dL; Hepatic:; Total bilirubin level ≤ 1.0 x UNL AST and ALT ≤ 3.0 x UNL Renal: Creatinine level ≤ 1.5 mg/dL in men, ≤1.4 mg/dL in women; or Estimated CCr ≥ 60 mL/min (CCr is estimated by Cockcroft-Gault formula); Negative pregnancy test for women of childbearing potential only; Patient willing to provide blood sample for research purposes; Written informed consent.
Exclusion: Other anti-tumor agent such as systemic chemotherapy, hormone therapy or surgery within 2 weeks before the commencement of study treatment or radiotherapy within 4 weeks before the commencement of study; Significant medical diseases, such as unstable angina, acute or recent myocardial infarction (<6 months before enrollment), COPD with frequent exacerbation, uncontrolled hypertension, ore cent CVA (<6 months before enrollment); Presence or history of malignancy disease other than endometrial cancer that has been diagnosed with past five years; Active uncontrolled infection; Pregnant or breastfeeding women, where pregnancy is confirmed by a positive hCG laboratory test; Poor compliance.