Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer
NCT ID: NCT02257619
Last Updated: 2018-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
9 participants
INTERVENTIONAL
2014-09-30
2016-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Itacitinib plus docetaxel
Itacitinib
Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.
docetaxel
Administered as an intravenous infusion in the clinic at 75 mg/m\^2 Q3W for Part 1 of the study.
Interventions
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Itacitinib
Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.
docetaxel
Administered as an intravenous infusion in the clinic at 75 mg/m\^2 Q3W for Part 1 of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease not including neoadjuvant and/or adjuvant therapy. (NOTE: Exceptions may be allowed based on prior treatment regimens and tumor types in agreement with protocol requirements.)
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
4. Life expectancy of ≥12 weeks.
Exclusion Criteria
2. Known active central nervous system (CNS) metastases. Subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to study entry, defined as:
1. No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
2. Subjects who are receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 4 weeks prior to first dose of study treatment and off all anticonvulsants for at least 4 weeks prior to study entry.
3. Peripheral neuropathy ≥ Grade 3.
4. Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.
5. Significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
6. Unwilling to be transfused with blood components.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Amit Pande, M.D.
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Hot Springs, Arizona, United States
Los Angeles, California, United States
Washington D.C., 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
Countries
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Other Identifiers
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INCB 39110-203
Identifier Type: -
Identifier Source: org_study_id
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