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Study of Itacitinib in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer
Sponsor: Incyte Corporation
Summary
The primary objectives of this study were to evaluate the safety and tolerability of itacitinib in combination with docetaxel and to select doses for further evaluation (Part 1, safety run-in portion), and to evaluate and compare the overall survival of subjects with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) when treated with itacitinib in combination with docetaxel versus docetaxel alone (Part 2, randomized portion).
Official title: A Randomized, Phase 2 Study of Itacitinib or Placebo in Combination With Docetaxel in Subjects With Previously Treated Stage IIIb, IV, or Recurrent Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
9
Start Date
2014-09-24
Completion Date
2016-04-05
Last Updated
2026-04-21
Healthy Volunteers
No
Conditions
Interventions
Itacitinib
Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.
docetaxel
Administered as an intravenous infusion in the clinic at 75 mg/m\^2 Q3W for Part 1 of the study.
Locations (16)
Hot Springs, Arizona, United States
Los Angeles, California, United States
Washington D.C., District of Columbia, United States
Orlando, Florida, United States
Detroit, Michigan, United States
Pascagoula, Mississippi, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Goldsboro, North Carolina, United States
Cleveland, Ohio, United States
Gettysburg, Pennsylvania, United States
Hershey, Pennsylvania, United States
Pawtucket, Rhode Island, United States
Spartanburg, South Carolina, United States
Round Rock, Texas, United States