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Clinical Trial Summary

The primary objectives of this study is 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).


Clinical Trial Description

Sponsor decision to not initiate part 2 of the trial and Part 2 of the study was not conducted.

In Part 2, the randomized portion, the objective is 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.

The secondary objectives of this study (Part 2) are 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02257619
Study type Interventional
Source Incyte Corporation
Contact
Status Terminated
Phase Phase 2
Start date September 2014
Completion date April 2016

See also
  Status Clinical Trial Phase
Terminated NCT02298153 - A Study of Atezolizumab (MPDL3280A) in Combination With Epacadostat (INCB024360) in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Previously Treated Stage IV Urothelial Carcinoma (ECHO-110) Phase 1
Terminated NCT02119650 - Ruxolitinib in Combination With Pemetrexed/Cisplatin in Non Small Cell Lung Cancer Phase 2
Withdrawn NCT02355431 - Itacitinib in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations Phase 2