Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT02213133
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor (KPT-330) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 22, 2014
Status verified
Jan 2023
Primary completion
Dec 10, 2015
Completion
Dec 10, 2015

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Percentage of Participants With Disease Control Rate (DCR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: up to 14.6 months ]

Locations (17)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado80045-
Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Northwestern UniversityEvanstonIllinois60208-
Dana-Farber Cancer Institute / Harvard UniversityBostonMassachusetts02215-
Tufts Medical CenterBostonMassachusetts02111-
Metrowest Medical CenterFraminghamMassachusetts01702-
Karmanos Cancer InstituteDetroitMichigan48201-
Washington University School of Medicine / Washington University in St. LouisSt LouisMissouri63130-
Hackensack University Medical CenterHackensackNew Jersey07601-
Herbert Irving Comprehensive Cancer Center / Columbia UniversityNew YorkNew York10032-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-6574-
Gabrail Cancer CenterCantonOhio44718-
Oregon Health and Science UniversityPortlandOregon97239-
Sarah Cannon Research Institute - Tennessee OncologyNashvilleTennessee37203-
Vanderbilt-Ingram Cancer Center / Vanderbilt UniversityNashvilleTennessee37232-
Mary Crowley Cancer Research Center / Texas OncologyDallasTexas75201-
University of WashingtonSeattleWashington63110-

Find similar trials in Aurora, CO

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OncologySkin cancerDermatology
By research site
University of Colorado Cancer Center· Aurora, COLee Moffitt Cancer Center and Research Institute· Tampa, FLNorthwestern University· Evanston, ILDana-Farber Cancer Institute / Harvard University· Boston, MATufts Medical Center· Boston, MAMetrowest Medical Center· Framingham, MA

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