TerminatedPhase 2

Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas

Stopped: Due to enrollment challenges and availability of other options for lung cancer patients. The termination is not a consequence of any safety concern.

United States45 participantsStarted 2014-09-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT02213133

SponsorKaryopharm Therapeutics Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12-10

Results submitted2020-11-06

View on ClinicalTrials.gov More Squamous Cell Carcinoma trials