NCT03095612

Phase 1/2 Trial of Selinexor (KPT-330) With Docetaxel for Non-small Cell Lung Cancer (NSCLC)

An Investigator-sponsored, Phase 1/2 Trial of the Oral XPO1 Inhibitor Selinexor (KPT-330) Monotherapy and in Combination With Docetaxel for Previously Treated, Advanced KRAS Mutant Non-small Cell Lung Cancer (NSCLC)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to evaluate the safety of the investigational study drug, selinexor when given with docetaxel to patients who have been previously treated for advanced KRAS mutant lung cancer.

Detailed 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).This study will compare safety and outcomes with historical controls (docetaxel monotherapy).

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Selinexor	Selinexor once weekly oral or twice weekly oral
DRUG	Docetaxel	Docetaxel once every 3 weeks (75 mg/m2 IV)

Timeline

• Start date: 2018-03-22
• Primary completion: 2022-11-08
• Completion: 2023-03-03
• First posted: 2017-03-29
• Last updated: 2024-06-13
• Results posted: 2024-06-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study