Status:
TERMINATED
Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer
Lead Sponsor:
National Cheng-Kung University Hospital
Collaborating Sponsors:
Chi Mei Medical Hospital
Kaohsiung Medical University
Conditions:
Endometrial Cancer Recurrent
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief 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 advance...
Detailed 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 mutat...
Eligibility Criteria
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
- Presence or history of malignancy disease other than endometrial cancer that has been diagnosed with past five years
- 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
- Active uncontrolled infection
- 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)
- Poor compliance
- Pregnant or breastfeeding women, where pregnancy is confirmed by a positive hCG laboratory test.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04030429
Start Date
September 1 2019
End Date
June 1 2025
Last Update
July 16 2025
Active Locations (1)
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1
National Cheng Kung University Hospital
Tainan, Taiwan, Taiwan, 704