Finding studies
Finding studies
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Lead
University of Southern California
With
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of FID-007 and the recommended phase II dose (RP2D). II. To determine the pharmacokinetics of paclitaxel, (free and total) in patients treated with FID-007. SECONDARY OBJECTIVES: I. To characterize the safety and tolerability of FID-007 by assessing toxicities per Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4.3. II. To obtain a preliminary assessment of anti-tumor activity of FID-007 via objective radiologic tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. EXPLORATORY OBJECTIVES: I. To evaluate in a preliminary fashion the serum concentration of total paclitaxel and free paclitaxel, and explore potential associations with serum concentrations, efficacy and toxicity. OUTLINE: This is a dose escalation study. Participants receive FID-007 intravenously (IV) over 60 minutes on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up periodically.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
