Study of Itacitinib in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer (NCT02257619) | Clinical Trial Compass
TerminatedPhase 2
Study of Itacitinib in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer
Stopped: Sponsor decision to not initiate part 2 due to slow enrollment and competing trials.
United States9 participantsStarted 2014-09-24
Plain-language summary
The primary objectives of this study were 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), and 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 (Part 2, randomized portion).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Number of Participants With Dose Limiting Toxicities (DLTs)
Timeframe: Baseline through 21 days; the end of cycle 1.
✕. 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.