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TERMINATED
NCT02257619
PHASE2

Study of Itacitinib in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

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

Interventions

DRUG

Itacitinib

Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.

DRUG

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