NCT02257619

Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer

A Randomized, Phase 2 Study of INCB039110 or Placebo in Combination With Docetaxel in Subjects With Previously Treated Stage IIIb, IV, or Recurrent Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• NSCLC (Non-small Cell Lung Carcinoma)

Interventions

Type	Name	Description
DRUG	Itacitinib	Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.
DRUG	docetaxel	Administered as an intravenous infusion in the clinic at 75 mg/m\^2 Q3W for Part 1 of the study.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-02-01
• Completion: 2016-04-01
• First posted: 2014-10-06
• Last updated: 2018-01-25

Locations

16 sites across 1 country: United States