cs-7017 in combination with erlotinib in subjects with stage iiib/iv non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the primary objectives of this study are to evaluate the safety and tolerability of cs-7017 administered orally twice a day in combination with erlotinib, and to assess the pharmacokinetics of cs-7017 in combination with erlotinib.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed unresectable locally advanced or metastatic (stage iiib or iv) non-small cell lung cancer (nsclc) * recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first-line platinum based therapy * male or female ≥ 18 years of age * anticipation of more than 3 months survival * eastern cooperative oncology group performance status (ecog ps) ≤ 1 * adequate organ and bone marrow function exclusion criteria: * prior tyrosine kinase inhibitor (tki) therapy * anticipation of need for a major surgical procedure or radiation therapy during the study * remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment * treatment with anticancer medication within 4 weeks before study treatment, currently enrolled in another investigational drug study, or enrolled in another investigational drug study within 4 weeks of start of treatment * history of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, new york heart association (nyha) class ≥i congestive heart failure (chf), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe chronic-obstructive pulmonary disease (copd) or asthma) * severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy * subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms) * subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis b surface antigen (hbsag)-, hepatitis c virus (hcv)- or human immunodeficiency virus (hiv)-positive or receiving antiretroviral therapy * subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction * diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications * treatment with thiazolidinedione(tzds) within 4 weeks prior to start of study treatment * history of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin * poorly-controlled blood pressure as judged by the investigator

Keywords: ppar gamma agonist tumor cancer antineoplastic agent respiratory tract neoplasms erlotinib protein kinase inhibitors neoplasms