NCT02120222

Evaluating SINE KPT-330 in Treating Patients With Melanoma That Cannot Be Removed By Surgery

A Phase 1 Expansion Cohort Evaluating the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Unresectable Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Kari Kendra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I clinical trial studies the side effects of selinexor in treating patients with melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as selinexor, may stop the growth of tumor cells, by stopping them from dividing.

Detailed description

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

Conditions

• Recurrent Melanoma

Interventions

Type	Name	Description
DRUG	selinexor	Given PO
OTHER	Correlative studies	Blood will be collected for pK and pDn analysis pretreatment on day 1 and 8 hours after treatment, on day 1 of cycles 1 and 2.

Timeline

• Start date: 2014-08-22
• Primary completion: 2018-04-08
• Completion: 2018-04-08
• First posted: 2014-04-22
• Last updated: 2023-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study