Non-small Cell Lung Cancer Metastatic Clinical Trial
Official title:
A Phase I/II Trial to Assess Safety and Tolerability of an Oral Aurora Kinase A Inhibitor, MLN8237, In Combination With Erlotinib In Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer
This phase I/II trial studies the side effects and the best dose of MLN8237 when given together with erlotinib hydrochloride and to see how well it works in treating patients with recurrent locally advanced or metastatic non-small cell lung cancer (NSCLC). MLN8237 and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. Safety and tolerability of the combination treatment. (Phase I) II. Maximum tolerated dose
(MTD) of MLN8237 (alisertib) when given in combination with standard dose erlotinib
(erlotinib hydrochloride). (Phase I) III. Progression free survival. (Phase II)
SECONDARY OBJECTIVES:
I. Pharmacokinetic (PK) parameters of erlotinib and MLN8237, including, but not limited to
maximum concentration of drug (Cmax), time of occurrence for maximum drug concentration
(Tmax), and area under the curve from time zero to the last measurable concentration(AUC0-t
last).
II. Overall response rate (ORR), duration of response (DOR), time to progression (TTP), and
overall survival (OS). (Phase II) III. Adverse events (AEs), serious adverse events (SAEs),
assessments of clinical laboratory values. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of alisertib followed by a phase II study.
Patients receive alisertib orally (PO) twice daily (BID) on days 1-7 and erlotinib
hydrochloride PO once daily (QD) on days 1-21. Courses repeat every 21 days for up to 2 years
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 2 years, and then annually thereafter.
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