Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Non -Small Cell Lung Cancer
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is a phase 1/2 single-arm, non-blinded, multi-institutional study. Selinexor will be administered once weekly starting one week before chemotherapy initiation (to permit pharmacodynamic assessment of selinexor alone and in combination with chemotherapy), in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Dose limiting toxicities (DLTs) will be assessed based on the first cycle (7-day lead-in plus 21-day cycle = 28 days) toxicity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03. A standard 3 + 3 dose escalation paradigm will be used.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This is a phase 1/2 clinical trial of the oral XPO1 inhibitor selinexor (KPT-330) in combination with docetaxel for previously treated, advanced KRAS mutant non-small cell lung cancer (NSCLC). It is a single-arm, non-blinded study, which will compare safety and outcomes with historical controls (doc...

This is a phase 1/2 clinical trial of the oral XPO1 inhibitor selinexor (KPT-330) in combination with docetaxel for previously treated, advanced KRAS mutant non-small cell lung cancer (NSCLC). It is a single-arm, non-blinded study, which will compare safety and outcomes with historical controls (docetaxel monotherapy). The multi-center study will be conducted within the Academic Thoracic Oncology Medical Investigator Consortium (ATOMIC).

Tracking Information

NCT #
NCT03095612
Collaborators
Karyopharm Therapeutics Inc
Investigators
Not Provided
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