Solid Tumor in Advanced Stage
Conditions
Keywords
Solid, Tumor, Taxane
Brief summary
Evaluation of pharmacokinetic profile of SPARC1028
Detailed description
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.
Interventions
DRUGSPARC1028
SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage which taxane-based therapy is a rational treatment option. * Age ≥18 years * ECOG Performance Status ≤ 1. * Estimated life expectancy of at least 12-weeks;
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 Maximum Tolerated Dose (MTD) during dose escalation | One 21-day treatment cycle | MTD for SPARC1028 will be determined as dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Establishing pharmacokinectic profile at each dose level for SPARC1028 | One 21-day treatment cycle | 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 |
Countries
United States
Outcome results
None listed