Status:
TERMINATED
Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer
Lead Sponsor:
Incyte Corporation
Conditions:
NSCLC (Non-small Cell Lung Carcinoma)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 sub...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV, or recurrent.
- 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.)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Life expectancy of ≥12 weeks.
Exclusion
- Received prior treatment with docetaxel.
- 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:
- No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
- 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.
- Peripheral neuropathy ≥ Grade 3.
- 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.
- Significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
- Unwilling to be transfused with blood components.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02257619
Start Date
September 1 2014
End Date
April 1 2016
Last Update
January 25 2018
Active Locations (16)
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1
Hot Springs, Arizona, United States
2
Los Angeles, California, United States
3
Washington D.C., District of Columbia, United States
4
Orlando, Florida, United States