Solid Tumor in Advanced Stage
Conditions
Keywords
solid, tumor, taxane, platinum
Brief summary
Phase I study of SPARC1023 alone and in combination with carboplatin
Detailed description
Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.
Interventions
DRUGSPARC1023 I
IV administration
DRUGSPARC1023 II
IV administration
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * ECOG Performance Status ≤ 1. * Estimated life expectancy of at least 12-weeks; * Measurable disease as per RECIST guideline (Version 1.1);
Exclusion criteria
* Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer * Known hypersensitivity to the study drugs * Treatment with any anti-cancer agents within 28 days of study entry * Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of MTD | One 21-day treatment cycle | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Establishing the pharmacokinetic profile | One 21-day treatment cycle | 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. |
Countries
United States
Outcome results
None listed