KEVETRIN PHASE 1 DATA POINTS-Credit TheProgressive
Primary Outcome Measures:
Dose Limiting Toxicities (DLT) of Kevetrin. [ Time Frame: up to 4 weeks ]
Maximum Tolerated Dose (MTD) of Kevetrin [ Time Frame: up to 6 months ]
DAY 1 TO TAKE PLACE ON/AROUND THURSDAY, NOV 1ST, 2012 (WITHIN A FEW DAY WINDOW)
Secondary Outcome Measures:
DAY 1 :
Pharmacokinetic Profile of Kevetrin [ Time Frame: Day 1 Pre-dose, 30 minutes after starting the infusion, 1 hr, 1 hr 10 min, 1 hr 20 min, 1 hr 30 min, 1 hr 45 min, 2 hr, 2 hr 30 min, 3 hr, 4 hr, 5 hr, 7 hr, and 24 hr after the initiation of the infusion ]
DAY 1 :
Changes in the biomarker p21 in peripheral blood lymphocytes [ Time Frame: baseline and 7 hours ]
DAY 1 :
Changes in the biomarker p21 in peripheral blood lymphocytes [ Time Frame: baseline and 24 hours ]
DAY 15 :
Pharmacokinetic Profile of Kevetrin [ Time Frame: Day 15 Pre-dose, 30 minutes after starting the infusion, 1 hr, 1 hr 10 min, 1 hr 20 min, 1 hr 30 min, 1 hr 45 min, 2 hr, 2 hr 30 min, 3 hr, 4 hr, 5 hr, 7 hr, and 24 hr after the initiation of the infusion ]
DAY 30 :
Decrease in serum tumor marker [ Time Frame: baseline and 1 month ]
DAY 60 :
Change in tumor size [ Time Frame: baseline and 2 months ]
DAY 60 :
Decrease in serum tumor marker [ Time Frame: baseline and 2 months ]
DAY 90 :
Decrease in serum tumor marker [ Time Frame: baseline and 3 months ]
DAY 120 :
Change in tumor size [ Time Frame: baseline and 4 months ]
DAY 120 :
Decrease in serum tumor marker [ Time Frame: baseline and 4 months ]
DAY 150 :
Decrease in serum tumor marker [ Time Frame: baseline and 5 months ]
DAY 180 :
Change in tumor size [ Time Frame: baseline and 6 months ]
DAY 180 :
Decrease in serum tumor marker [ Time Frame: baseline and 6 months ]
That sums it up. That is what we will learn, and in proper chronological order. Very exciting, the will be trial data on a regular basis, lots of talking points and PR material.
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