Finding studies
Finding studies
Take this into the appointment.
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Lead
National Cancer Institute (NCI)
With
PRIMARY OBJECTIVES: I. To determine the toxicity profile and the maximum tolerated doses (MTDs) of dabrafenib in patients with v-raf murine sarcoma viral oncogene homolog B1 (BRAF)\^V600X mutations and renal or hepatic dysfunction. SECONDARY OBJECTIVES: I. To assess for tumor response and various times to clinical event. II. To provide dosing recommendations for dabrafenib in patients with varying degrees of hepatic and renal dysfunction for possible inclusion in the label. TERTIARY OBJECTIVES: I. To assess the pharmacokinetic and pharmacogenetic profile of dabrafenib and active metabolites. OUTLINE: This is a dose-escalation study. Patients receive dabrafenib orally (PO) twice daily (BID) on days 1-28 (once daily \[QD\] on day 1 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
