Brief Title
Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer
Official Title
Phase II Trial of Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer
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 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.
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 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Change in best overall response rate
Secondary Outcome
Progression-free survival
Condition
Endometrial Cancer Recurrent
Intervention
Crizotinib 250 MG
Study Arms / Comparison Groups
Crizotinib arm
Description: Crizotinib 250 mg bid orally
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
September 1, 2019
Completion Date
February 2024
Primary Completion Date
February 2024
Eligibility Criteria
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.
Gender
All
Ages
20 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Keng-Fu Hsu, PhD, +886-6-2353535, [email protected]
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT04030429
Organization ID
B-BR-108-016
Responsible Party
Sponsor
Study Sponsor
National Cheng-Kung University Hospital
Collaborators
Chi Mei Medical Hospital
Study Sponsor
Keng-Fu Hsu, PhD, Principal Investigator, National Cheng-Kung University Hospital
Verification Date
April 2022