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
Kari Kendra
With
PRIMARY OBJECTIVES: I. To estimate safety of KPT-330 (selinexor) in patients with melanoma at the maximum tolerated dose (MTD) defined by the phase 1 study. SECONDARY OBJECTIVES: I. To determine the clinical benefit rate (CBR) (complete response, partial response, and stable disease) of patients with unresectable melanoma. II. To assess the efficacy at the MTD as measured by progression free survival (PFS) in patients with melanoma. TERTIARY OBJECTIVES: I. To validate nuclear transport inhibition resulting from treatment. II. To assess if v-raf murine sarcoma viral oncogene homolog B1 (BRAF), neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS), or platelet-derived growth factor receptor, beta polypeptide (PDGFRB) mutational status impacts response. III. To assess alteration in signaling pathways as a result of therapy with KPT-330. IV. To assess immunologic changes resulting from treatment with KPT-330. OUTLINE: Patients receive selinexor orally (PO) twice weekly (BIW). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 1 year
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
