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Phase I Study of Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC
The main purpose of this study is to find out what effects (good and bad) ceritinib (Zykadia®) used in combination with docetaxel (Taxotere®) will have on participants and their cancer. The results will help to determine the best safe dose of the combination of the medications Ceritinib (Zykadia®) and docetaxel (Taxotere®) and to find out if this combination of drugs will help people that have this type of Non-small Cell Lung Cancer (NSCLC).
Primary Objective: Phase I escalation (ceritinib plus docetaxel) -Determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of concurrent administration of ceritinib and docetaxel and describe adverse event profile. Primary Objective for Phase Ib (single arm cohort) -Estimate response rates of patients treated with ceritinib and docetaxel Secondary Objectives for Phase Ib (single arm cohort) -Determine the overall survival (OS), disease control rate (DCR), and progression-free survival (PFS) of patients treated with ceritinib and docetaxel -Examine potential predictive markers in the tumors of clinical responders
Chemotherapy (NOS); Therapy (NOS)
Ceritinib (Zykadia); Taxotere (docetaxel); docetaxel ()
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