drugset / Trial / NCT02257619

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

NCT02257619 ↗

Phase 2 Terminated 9 enrolled Incyte Corporation
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2014-09-24
Primary completion
2016-02
Completion
2016-04-05

Outcome

Outcome not reported

Stopped (Enrollment): “Sponsor decision to not initiate part 2 due to slow enrollment and competing trials.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Itacitinib Small molecule 400 mg Oral
Background Docetaxel Small molecule 75 mg/m2 Intravenous