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).
The secondary objectives of this study (Part 2) were to evaluate and compare the efficacy of the 2 treatment groups with respect to progression-free survival, overall tumor response, and duration of response, and to evaluate and compare disease control, safety, and tolerability of itacitinib in combination with docetaxel versus docetaxel alone. Part 2 of the study was not conducted.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.
Administered as an intravenous infusion in the clinic at 75 mg/m\^2 Q3W for Part 1 of the study.
Unnamed facility
Hot Springs, Arizona, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Number of Participants With Dose Limiting Toxicities (DLTs)
Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD).
Time frame: Baseline through 21 days; the end of cycle 1.
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Unnamed facility
Orlando, Florida, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Pascagoula, Mississippi, United States
Unnamed facility
Kansas City, Missouri, United States
Unnamed facility
Omaha, Nebraska, United States
Unnamed facility
Lebanon, New Hampshire, United States
Unnamed facility
Goldsboro, North Carolina, United States
...and 6 more locations