Pharmacokinetic, Safety and Tolerability Study of SPARC1028

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 1

Conditions: Solid Tumor in Advanced Stage

Treatments: Drug: SPARC1028

Study type: Interventional

Funder types: Industry

Identifiers

NCT01305512

CLR_10_28

Details and patient eligibility

About

Evaluation of pharmacokinetic profile of SPARC1028

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

SPARC1028

Experimental group

Treatment:

Drug: SPARC1028