Ignite Creation Date:
2024-05-06 @ 3:08 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02219711
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2014-08-14
Brief Title:
Phase 11b Study of MGCD516 in Patients With Advanced Cancer
Sponsor:
Mirati Therapeutics Inc
Organization:
Mirati Therapeutics Inc
Study Overview
Official Title:
A Phase 11b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
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:
MGCD516 is a receptor tyrosine kinase RTK inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET AXL MER and members of the VEGFR PDGFR DDR2 TRK and Eph families In this study MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety pharmacokinetic metabolism pharmacodynamic and clinical activity profiles
During the Phase 1 segment the dose and regimen of MGCD516 will be assessed during the Phase 1b segment the clinical activity of MGCD516 will be evaluated in selected patient populations
Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type including but not limited to non small cell lung cancer and head and neck cancer positive for specific activating MET NTRK2 NTRK3 or DDR2 mutations MET or KITPDGFRAKDR gene amplification selected gene rearrangements involving the MET RET AXL NTRK1 or NTRK3 gene loci or having loss of function mutations in the CBL gene In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled
During the Phase 1 segment the dose and regimen of MGCD516 will be assessed during the Phase 1b segment the clinical activity of MGCD516 will be evaluated in selected patient populations
Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type including but not limited to non small cell lung cancer and head and neck cancer positive for specific activating MET NTRK2 NTRK3 or DDR2 mutations MET or KITPDGFRAKDR gene amplification selected gene rearrangements involving the MET RET AXL NTRK1 or NTRK3 gene loci or having loss of function mutations in the CBL gene In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled
Detailed Description:
During the Phase 1 segment the dose and regimen of MGCD516 will be assessed
During the Phase 1b segment the clinical activity of MGCD516 will be evaluated in selected patient populations Patients anticipated to be enrolled in Phase 1b will be selected based upon the following cancer diagnosis
Non-small cell lung cancer with genetic alterations in MET AXL RET TRK DDR2 KDR PDGFRA KIT or CBL
Head and neck squamous cell carcinoma with genetic alterations in MET
Clear cell renal cell carcinoma refractory to angiogenesis inhibitors
Metastatic prostate cancer with bone metastases
Other cancer diagnosis having a selected genetic alteration in MGCD516 target RTKs
During the Phase 1b segment the clinical activity of MGCD516 will be evaluated in selected patient populations Patients anticipated to be enrolled in Phase 1b will be selected based upon the following cancer diagnosis
Non-small cell lung cancer with genetic alterations in MET AXL RET TRK DDR2 KDR PDGFRA KIT or CBL
Head and neck squamous cell carcinoma with genetic alterations in MET
Clear cell renal cell carcinoma refractory to angiogenesis inhibitors
Metastatic prostate cancer with bone metastases
Other cancer diagnosis having a selected genetic alteration in MGCD516 target RTKs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None