Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas
NCT ID: NCT02213133
Last Updated: 2023-01-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
45 participants
INTERVENTIONAL
2014-09-22
2015-12-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Head and Neck-SCC
Participants with advanced squamous cell carcinoma (SCC) of head and neck, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 milligram (mg) selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets less than \[\<\] 100\*10\^9 per litre \[/L\]), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
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.
Cohort 2: Lungs-SCC
Participants with advanced SCC of lungs, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets \<100\*10\^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
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.
Cohort 3: Esophagus-SCC
Participants with advanced SCC of esophagus, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets \<100\*10\^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Karyopharm Therapeutics Inc
INDUSTRY
Responsible Party
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Locations
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University of Colorado Cancer Center
Aurora, Colorado, United States
Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Northwestern University
Evanston, Illinois, United States
Tufts Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute / Harvard University
Boston, Massachusetts, United States
Metrowest Medical Center
Framingham, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School of Medicine / Washington University in St. Louis
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Herbert Irving Comprehensive Cancer Center / Columbia University
New York, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center / Vanderbilt University
Nashville, Tennessee, United States
Mary Crowley Cancer Research Center / Texas Oncology
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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KCP-330-006
Identifier Type: -
Identifier Source: org_study_id
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