Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas

Squamous Cell Carcinoma Clinical Trial

— STARRS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02213133
• Other study ID #: KCP-330-006
• Status: Terminated
• Phase: Phase 2
• Start date: September 22, 2014
• Est. completion date: December 10, 2015

Study information

• Verified date: January 2023
• Source: Karyopharm Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: December 10, 2015
• Est. primary completion date: December 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

Drug:
• Selinexor (KPT-330)
Oral tablet or suspension at 60, 80, 100 or 120 mg per patient-specific body surface area category. Dosing will occur twice weekly in 28-days cycle.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Dana-Farber Cancer Institute / Harvard University	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Gabrail Cancer Center	Canton	Ohio
United States	Mary Crowley Cancer Research Center / Texas Oncology	Dallas	Texas
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Northwestern University	Evanston	Illinois
United States	Metrowest Medical Center	Framingham	Massachusetts
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Sarah Cannon Research Institute - Tennessee Oncology	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center / Vanderbilt University	Nashville	Tennessee
United States	Herbert Irving Comprehensive Cancer Center / Columbia University	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Oregon Health and Science University	Portland	Oregon
United States	Washington University School of Medicine / Washington University in St. Louis	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington
United States	Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Karyopharm Therapeutics Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Disease Control Rate (DCR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	DCR was defined as the best overall response of complete response (CR), partial response (PR), or stable disease (SD). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Participant response was evaluated by physical examinations and computed tomography (CT)/Magnetic Resonance Imaging (MRI) (or optional positron emission tomography [PET]/CT) and assessed by RECIST 1.1 criteria.	up to 14.6 months
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An adverse event (AE) was defined as any unfavorable sign and unintended sign (including abnormal laboratory finding), symptom, or disease temporarily associated with the use of the study drug, whether or not related to study drug. An SAE was defined as any untoward medical occurrence that occurs at any dose (including after informed consent was signed and prior to dosing) that resulted in death, was life-threatening (participant was at immediate risk of death from event), required in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect, and important medical events. A TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after first dose of treatment through 30 days following last dose of study treatment, or any event considered drug-related by investigator through end of study.	From the first administration of study drug up to 30 days follow-up (up to 14.6 months)
Secondary	Number of Participants With Treatment-emergent Adverse Events by Severity: Clinical Terminology Categories for Adverse Events (CTCAE) Grading Scale	AE:Any unfavorable sign and unintended sign,symptom, or disease temporarily associated with use of study drug, whether or not related to it. SAE:Any untoward medical occurrence that occurs at any dose (after informed consent was signed, prior dosing) that resulted in death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and important medical events. TEAE:Any AE with onset or worsening of existing condition on or after first dose through 30 days following last dose of study drug, or any event considered drug-related by investigator through end of study. Severity(Grades 1 to 5) of each AE was categorized as either mild=1(transient,does not interfere with daily activities), moderate=2(low level of inconvenience or concern,interfere with daily activities), severe=3(interrupt usual daily activities), life threatening=4 or fatal=5, higher grade reported worst outcome.	From the first administration of study drug up to 30 days follow-up (up to 14.6 months)