Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of Chicago
With
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of mifepristone when given in combination with carboplatin and gemcitabine (gemcitabine hydrochloride). SECONDARY OBJECTIVES: I. To determine the safety and tolerability of mifepristone in combination with carboplatin and gemcitabine. II. To describe the toxicities seen with carboplatin, gemcitabine, and mifepristone combination therapy. TERTIARY OBJECTIVES: I. To correlate expression of biomarkers (e.g. glucocorticoid receptor \[GR\], androgen receptor \[AR\], estrogen receptor \[ER\], and progesterone receptor \[PR\]) with treatment outcomes. II. To correlate serum and intratumoral mifepristone concentrations after two doses of mifepristone (in patients with easily accessible tumor who consent to an optional research biopsy). OUTLINE: This is a dose-escalation study of mifepristone. Patients receive mifepristone orally (PO) once daily (QD) on days 0, 1, 7, and 8, and carboplatin intravenously (IV) over 30 minutes and gemcitabine hydrochloride IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 18 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
