drugset / Trial / NCT02257619
Study of Itacitinib in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itacitinib | Small molecule | 400 mg | Oral |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |