Study of Itacitinib in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer
NCT02257619 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2026-04-21
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).
Conditions
- NSCLC (Non-small Cell Lung Carcinoma)
Interventions
- DRUG
-
Itacitinib
Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.
- DRUG
-
Administered as an intravenous infusion in the clinic at 75 mg/m\^2 Q3W for Part 1 of the study.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Amit Pande, M.D. · Incyte Corporation
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-24
- Primary Completion
- 2016-02-29
- Completion
- 2016-04-05
- FDA Drug
- Yes
Countries
- United States
Study Locations
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