Back to resultsCrizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer
Primary Purpose
Endometrial Cancer Recurrent
Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Crizotinib 250 MG
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer Recurrent
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.
Sites / Locations
- National Cheng Kung University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Crizotinib arm
Arm Description
Crizotinib 250 mg bid orally
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Overall survival
Overall survival is defined as defined as the time from the start of treatment to death from any cause.
Full Information
NCT ID
NCT04030429
First Posted
May 24, 2019
Last Updated
June 6, 2022
Sponsor
National Cheng-Kung University Hospital
Collaborators
Chi Mei Medical Hospital, Kaohsiung Medical University, Kaohsiung Veterans General Hospital.
1. Study Identification
Unique Protocol Identification Number
NCT04030429
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
Chi Mei Medical Hospital, Kaohsiung Medical University, Kaohsiung Veterans General Hospital.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer Recurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Crizotinib arm
Arm Type
Experimental
Arm Description
Crizotinib 250 mg bid orally
Intervention Type
Drug
Intervention Name(s)
Crizotinib 250 MG
Other Intervention Name(s)
Xalkori 250 MG
Intervention Description
bid orally
Primary Outcome Measure Information:
Title
Change in best overall response rate
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.
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
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
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
Title
Overall survival
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keng-Fu Hsu, PhD
Phone
+886-6-2353535
Ext
5222
Email
d5580@mail.ncku.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keng-Fu Hsu, PhD
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keng-Fu Hsu, MD., PhD.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer
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