Dr.Menon and Leo know exactly what we got when it comes to Kevetrin because the the study design is straight to the point when it comes to secondary outcomes. They are doing imaging studies and serum marker collections up through 6 months post baseline so by now they should have plenty of data and the further we go in the trial the more statistically significant it becomes so when it comes time we can apply for BReak Through designation.
This is my opinion also but I feel confident that this year will be the year for CTIX!!!!
From clinical trials website:
Change in tumor size [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ]
Change in tumor size based on RECIST criteria version 1.1. using MRI, CT scan, and/or standard of care imaging
Change in tumor size [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
Change in tumor size based on RECIST criteria version 1.1. using MRI, CT scan, and/or standard of care imaging
Change in tumor size [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
Change in tumor size based on RECIST criteria version 1.1. using MRI, CT scan, and/or standard of care imaging
Decrease in serum tumor marker [ Time Frame: baseline and 1 month ] [ Designated as safety issue: No ]
A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), Prostate Specific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of the patient and the testing that has preceded the patient's participation in this study.
Decrease in serum tumor marker [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ]
A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), Prostate Specific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of the patient and the testing that has preceded the patient's participation in this study.
Decrease in serum tumor marker [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), Prostate Specific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of the patient and the testing that has preceded the patient's participation in this study.
Decrease in serum tumor marker [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), Prostate Specific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of the patient and the testing that has preceded the patient's participation in this study.
Decrease in serum tumor marker [ Time Frame: baseline and 5 months ] [ Designated as safety issue: No ]
A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), Prostate Specific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of the patient and the testing that has preceded the patient's participation in this study.
Decrease in serum tumor marker [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), Prostate Specific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of the patient and the testing that has preceded the patient's participation in this study.
Changes in the biomarker p21 in peripheral blood lymphocytes [ Time Frame: baseline and 7 hours ] [ Designated as safety issue: No ]
For biomarker analysis, p21 expression, assayed by qPCR, in peripheral blood lymphocytes after Kevetrin administration.
Changes in the biomarker p21 in peripheral blood lymphocytes [ Time Frame: baseline and 24 hours ] [ Designated as safety issue: No ]
For biomarker analysis, p21 expression, assayed by qPCR, in peripheral blood lymphocytes after Kevetrin administration.
