CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: CS-7017; Erlotinib
Intervention description: CS-7017 from 0.25 mg to 0.50 mg twice daily; Erlotinib 150 mg once daily
Intervention MeSH terms: Erlotinib Hydrochloride; Efatutazone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PPAR gamma agonist; Tumor; Cancer; Antineoplastic Agent; Respiratory Tract Neoplasms; Erlotinib; Protein Kinase Inhibitors; Neoplasms

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