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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPARC1028 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARC1028 | Drug | SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One 21-day treatment cycle |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One 21-day treatment cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPARC Site 1 | Buffalo | New York | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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