Spots Global Cancer Trial Database for Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer
Official Title: 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
Study ID: NCT02257619
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Hot Springs, Arizona, United States
, Los Angeles, California, United States
, Washington, District of Columbia, United States
, Orlando, Florida, United States
, Detroit, Michigan, United States
, Pascagoula, Mississippi, United States
, Kansas City, Missouri, United States
, Omaha, Nebraska, United States
, Lebanon, New Hampshire, United States
, Goldsboro, North Carolina, United States
, Cleveland, Ohio, United States
, Gettysburg, Pennsylvania, United States
, Hershey, Pennsylvania, United States
, Pawtucket, Rhode Island, United States
, Spartanburg, South Carolina, United States
, Round Rock, Texas, United States
Contact Details
Name: Amit Pande, M.D.
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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