Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas

A Phase 2, Open-Label Study of the Safety and Efficacy of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck, Lung, or Esophagus

Open-label, multi-center, single-arm, Phase 2 study of oral selinexor in patients with SCC of the head and neck (HN-SCC; Cohort 1), lung (L-SCC; Cohort 2), or esophagus (E-SCC; Cohort 3) who have relapsed or have metastasis following chemotherapy.

This is a multicenter, open-label, single-arm Phase 2 study of the SINE selinexor given orally to patients diagnosed with advanced SCC of the head and neck, lung, or esophagus who have experienced relapse and/or metastasis following multiple prior chemotherapy treatments (<2 lines of therapy).

Patients will receive fixed doses of selinexor tablets twice weekly in 28-day cycles. Patients may continue from one cycle to the next without interruption as along as all criteria are met and no reason for discontinuation occurs.

Inclusion Criteria:

• 18 years of age or older
• confirmed SCC of the head and neck, lung, or esophagus
• 1 to 2 prior therapies
• measurable disease at screening and documented progression within the past 6 weeks

Exclusion Criteria:

• patients requiring total parenteral nutrition
• unstable cardiovascular function
• substantially impaired gastrointestinal function
• Symptomatic brain metastases
• another malignancy within 3 years except adequately treated in situ carcinoma of any type, basal or non-melanomatous skin cancer