Phase I study of SPARC1023 alone and in combination with carboplatin
Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
IV administration
IV administration
SPARC Site 1
Buffalo, New York, United States
Determination of MTD
MTD for SPARC1023 in combination with carboplatin will be determined. MTD will be defined as the SPARC1023 dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects.
Time frame: One 21-day treatment cycle
Establishing the pharmacokinetic profile
Plasma levels of SPARC1023 and Carboplatin will be determined and PK parameters viz. Cmax, AUC0-t, AUC 0-∞, MRT, Tmax, t½ , Kel, Vd for SPARC1023 in combination with carboplatin will be evaluated.
Time frame: One 21-day treatment cycle
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