Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

Completed · Phase 1

Conditions studied: Solid Tumor in Advanced Stage

In brief

Phase I study of SPARC1023 alone and in combination with carboplatin

Key facts

Study ID

NCT01304303

Run by

Sun Pharma Advanced Research Company Limited

People needed

57

Starts

2011-10-01

Expected to finish

2016-10-01

Last updated by the study team

2019-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• ECOG Performance Status ≤ 1.
• Estimated life expectancy of at least 12-weeks;
• Measurable disease as per RECIST guideline (Version 1.1);

You may not qualify if…

• 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

Where it is running

• SPARC Site 1 — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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