Pharmacokinetic, Safety and Tolerability Study of SPARC1028

Completed · Phase 1

Conditions studied: Solid Tumor in Advanced Stage

In brief

Evaluation of pharmacokinetic profile of SPARC1028

Key facts

Study ID

NCT01305512

Run by

Sun Pharma Advanced Research Company Limited

People needed

36

Starts

2012-05-01

Expected to finish

2016-08-01

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…

• 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;

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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