A Phase 2 interventional study of Crizotinib 250 MG in Endometrial Cancer Recurrent, sponsored by National Cheng-Kung University Hospital. Terminated at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by National Cheng-Kung University Hospital · Phase 2, Interventional, and Treatment
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.
National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria:
Crizotinib 250 mg bid orally
Drug: Crizotinib 250 MG
bid orally
Also known as: Xalkori 250 MG
Change in best overall response rate
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.
Time frame: CT scan or MRI will be done at baseline and at the end of every 2 cycles (each cycle is 28 days) until the date of first documented progression or date of death from any cause, whichever came first, up to 104 weeks
Progression-free survival
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.
Time frame: CT scan or MRI will be done at baseline and at the end of every 2 cycles (each cycle is 28 days) until the date of first documented progression or date of death from any cause, whichever came first, up to 104 weeks
Overall survival
Overall survival is defined as defined as the time from the start of treatment to death from any cause.
Time frame: Overall survival will be followed from the start of treatment to death from any cause, up to 104 weeks
Plan to share: No
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This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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National Cheng-Kung University Hospital