Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas

Status:	Terminated
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	8/31/2018
Start Date:	July 2014
End Date:	August 2016

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

We found this trial at

sites

Dana-Farber Cancer Institute Harvard University

Boston, Massachusetts

from

Boston, MA