The purpose of this study is to determine if the experimental drug, SG2000 is safe and tolerable in the treatment of participants with advanced chronic lymphocytic leukemia and acute myeloid leukemia whose standard treatment did not work, whose cancer came back or who are not candidates for other types of standard therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
intravenous doses given on Days 1, 2, and 3 of each 21-day cycle (1 to 6 cycles).
Duke University
Durham, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Maximum Tolerated Dose (MTD) of SG2000.
The Maximum Tolerated Dose (MTD) will be determined based on the assessment of the dose-limiting toxicity (DLT) during the DLT period; period is defined as the time from the first dose intravenous doses of SG2000 for 3 consecutive days every 21 days for 1 to 6 cycles until unacceptable toxicity, consent withdrawal, or another reason to discontinue therapy intervenes.
Time frame: From 1st dose of SG2000 given on days 1, 2 and 3, every 21-days, for six 21-day cycles (approximately 16 weeks).
safety profile
Any subject who receives at least 1 dose of SG2000 will be evaluated for safety. Subjects will be monitored for adverse events (AEs) and will undergo safety assessments including full physical examination, vital sign assessment, Eastern Cooperative Oncology Group (ECOG) performance status assessment, and laboratory testing.
Time frame: day -1 to day- 21 for six 21-day cycles .
area under the concentration-time curve (AUC)
pharmacokinetic (PK) parameter, noncompartmental analysis will be performed to estimate the plasma pharmacokinetic (PK) parameters of SG2000. Area under the concentration-time curve (AUC).
Time frame: day-1 of each 21-day cycle (cycles 1 and 3) at the following time points: predose, 15 minutes (middle of infusion), 30 minutes(end of infusion), and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after the end of infusion.
Maximum plasma concentration (Cmax)
pharmacokinetic (PK) parameter -Cmax is the observed maximum plasma or serum concentration after administration
Time frame: day-1 of each 21-day cycle (cycles 1 and 3) at the following time points: predose, 15 minutes (middle of infusion), 30 minutes (end of infusion), and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after the end of infusion.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
time to reach Cmax
pharmacokinetic (PK) parameter - time to reach Cmax.
Time frame: day-1 of each 21-day cycle (cycles 1 and 3) at the following time points: predose, 15 minutes (middle of infusion), 30 minutes (end of infusion), and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after the end of infusion.
terminal half life (T1/2),
pharmacokinetic parameter - terminal half life
Time frame: day-1 of each 21-day cycle (cycles 1 and 3) at the following time points: predose, 15 minutes (middle of infusion), 30 minutes (end of infusion), and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after the end of infusion.
hematology and serum chemistry
predictors of Vascular Leak Syndrome (VLS)
Time frame: baseline, days 1,2,3,4,8,15, and 21 for six 21-day cycles.
Physical examination
predictors of Vascular Leak Syndrome (VLS)
Time frame: baseline, day-1 to day 21 for six 21-day cycles.
Vital signs
predictors of Vascular Leak Syndrome (VLS)
Time frame: baseline, day-1 to day-21 for six 21-day cycles.
bone marrow aspirate
Time frame: day-1 (predose), and day 8 of Cycles 1 and 3 , and day 1 of Cycles 2 and 4
pulse oximetry
monitoring for Vascular Leak Syndrome (VLS)
Time frame: baseline, day-1 to day-21 for six 21-day cycles.
electrocardiogram
Time frame: days 1, 8, 15, 21, and at Day 22 after the last cycle or early termination.
bone marrow aspirate
Time frame: day-1 (predose), and day- 8 of each 21-day cycle (cycles 1 and 3) and day -1 of cycles 2 and 4