Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors

Phase 1/2 Completed 55 enrolled Incyte Corporation

NaSingle-groupOpen-labelTreatment

Summary

Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.

Timeline

Start: 2013-06
Primary completion: 2016-02
Completion: 2016-03

Publications

Beatty GL, Shahda S, Beck T, Uppal N, Cohen SJ, Donehower R, Gabayan AE, Assad A, Switzky J, Zhen H, Von Hoff DD. A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors. Oncologist. 2019 Jan;24(1):14-e10. doi: 10.1634/theoncologist.2017-0665. Epub 2018 Aug 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	750 mg/m2	—
Subject	Gemcitabine	Small molecule	1000 mg/m2	—
Subject	Itacitinib	Small molecule	200 mg	—
Subject	Itacitinib	Small molecule	300 mg	—
Subject	Itacitinib	Small molecule	400 mg	—
Subject	Paclitaxel	Small molecule	100 mg/m2	—
Subject	Paclitaxel	Small molecule	125 mg/m2	—
Background	filgrastim	Protein / enzyme biologic	—	—

Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications