Clinical trial · Interventional
Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer
Phase II Trial of Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Patients were recruited during screen phase but fewer patients met criteria.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Crizotinib 250 MG | Drug | Crizotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Crizotinib arm
- description
- Crizotinib 250 mg bid orally
- interventionNames
- Drug: Crizotinib 250 MG
Primary outcomes (1)
- measure
- Change in best overall response rate
- timeFrame
- 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
- description
- 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.
Secondary outcomes (2)
- measure
- Progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available