Clinical trial NCT02213133: Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma
Keywords: Squamous
SCC
Carcinoma
KPT-330
SINE
Selinexor
Karyopharm
Karyopharm Therapeutics
Lung
Head
Neck
Esophageal
Lead sponsor: Karyopharm Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2014-08-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Disease Control Rate (DCR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
timeFrame: up to 14.6 months
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From the first administration of study drug up to 30 days follow-up (up to 14.6 months)
measure: Number of Participants With Treatment-emergent Adverse Events by Severity: Clinical Terminology Categories for Adverse Events (CTCAE) Grading Scale
timeFrame: From the first administration of study drug up to 30 days follow-up (up to 14.6 months)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Tampa
country: United States
facility: Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute / Harvard University
state: Massachusetts
city: Framingham
country: United States
facility: Metrowest Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine / Washington University in St. Louis
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center / Columbia University
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Nashville
country: United States
facility: Sarah Cannon Research Institute - Tennessee Oncology
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center / Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Cancer Research Center / Texas Oncology
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
References: