Evaluation of pharmacokinetic profile of SPARC1028
This is a phase I study of SPARC1028 and recommend phase II dose of SPARC1028 administered once a week for 3 weeks, followed by 1 week of rest.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest
SPARC Site 1
Buffalo, New York, United States
Determination of Maximum Tolerated Dose (MTD) during dose escalation
MTD for SPARC1028 will be determined as dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects
Time frame: One 21-day treatment cycle
Establishing pharmacokinectic profile at each dose level for SPARC1028
Plasma levels of SPARC1028 will be determined and PK parameters viz., Cmax, AUC0-t, AUC0-∞, MRT, Tmax, t½, Kel, Vd, Cl for SPARC1028 will be evaluated
Time frame: One 21-day treatment cycle
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