Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas

• Status: Terminated
• Trial end date: 2015-12-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karyopharm Therapeutics Inc; Karyopharm Therapeutics, Inc

Criteria

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