Pharmacokinetic, Safety and Tolerability Study of SPARC1028
- Registration Number
- NCT01305512
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SPARC1028 SPARC1028 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
SPARC Site 1
🇺🇸Buffalo, New York, United States