Ignite Creation Date:
2024-05-06 @ 1:29 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04030429
Status:
UNKNOWN
Last Update Posted:
2022-06-08
First Post:
2019-05-24
Brief Title:
Crizotinib in c-MET Mutation MetastaticRecurrentPersistent Endometrial Cancer
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
Phase II Trial of Crizotinib in c-MET Mutation MetastaticRecurrentPersistent Endometrial Cancer
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None