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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPARC1023 I | Experimental |
| |
| SPARC1023 II | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARC1023 I | Drug | IV administration |
| |
| SPARC1023 II |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One 21-day treatment cycle |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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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| Drug |
IV administration |
|