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Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas (STARRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02213133
Recruitment Status : Terminated (Due to enrollment challenges and availability of other options for lung cancer patients. The termination is not a consequence of any safety concern.)
First Posted : August 11, 2014
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma Drug: Selinexor (KPT-330) Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 for the first 3 weeks of each 4-week cycle. Duration of treatment is open-ended and patients will dose as long as the dose is tolerated and participation is voluntarily given, until disease progression occurs.
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.
Other Name: KPT-330




Primary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: for a minimum of 12 weeks post treatment initiation ]
    defined as complete or partial response, or stable disease



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213133


Locations
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United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern University
Evanston, Illinois, United States, 60208
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Dana-Farber Cancer Institute / Harvard University
Boston, Massachusetts, United States, 02215
Metrowest Medical Center
Framingham, Massachusetts, United States, 01702
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University School of Medicine / Washington University in St. Louis
Saint Louis, Missouri, United States, 63130
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6574
Herbert Irving Comprehensive Cancer Center / Columbia University
New York, New York, United States, 10032
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Tennessee
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Center / Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Mary Crowley Cancer Research Center / Texas Oncology
Dallas, Texas, United States, 75201
United States, Washington
University of Washington
Seattle, Washington, United States, 63110
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
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Study Director: Michael Kauffman, MD, PhD Karyopharm Therapeutics Inc

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Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02213133     History of Changes
Other Study ID Numbers: KCP-330-006
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Karyopharm Therapeutics Inc:
Squamous
SCC
Carcinoma
KPT-330
SINE
Selinexor
Karyopharm
Karyopharm Therapeutics
Lung
Head
Neck
Esophageal
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell