Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase I study of SPARC1023 alone and in combination with carboplatin

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Criteria

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