Clinical Study of Oral IGF-1R Inhibitor in Subjects With Advanced Refractory Solid Tumors

Inclusion Criteria: * Subjects having histologically and/or cytologically confirmed non-haematological malignancy that is metastatic or unresectable and for which standard curative or palliative treatment does not exist or is no longer effective * Subjects should have measurable or evaluable disease * Subjects of either sex, of all races and ethnic groups, and ≥18 years of age * ECOG (Eastern Cooperative Oncology Group) performance status 0-1 * Subjects with life expectancy of at least 4 months * Subjects with fasting plasma glucose ≤ 125 mg/dL and HbA1c \< 6.5 % at screening Subjects with fasting plasma glucose ≤150 mg/dL and HbA1c ≤ 7.0 % at screening for the Diabetes Expansion Cohort. * For the Diabetes Expansion Cohort - Subjects with known history of type 2 diabetes mellitus that are well-controlled on a stable dose of oral anti-diabetic agents such as metformin and/or sulfonylureas for 4 weeks prior to screening. * Subjects must have normal organ and marrow function as defined below: 1. Absolute neutrophil count ≥ 1500/cmm 2. Platelets ≥ 100,000/cmm 3. Total bilirubinwithin normal limits of the institution 4. AST/ALT ≤ 2.5 X institutional upper limit of normal (ULN) or ≤ 5 X institutional upper limit of normal (ULN) in the presence of liver metastases 5. Creatinine ≤ 1.5 X institutional upper limit of normal (ULN) * Subjects willing for repeat oral dosing and follow-up, including pharmacokinetic sampling * Women of childbearing potential and men willing to agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilised * Ability to understand and the willingness to provide a written informed consent document Exclusion Criteria * Subjects who have received any prior chemotherapy, radiotherapy, biologic/targeted anti-cancer therapy or surgery within 4 weeks (6 weeks for monoclonal antibodies, radioactive monoclonal antibodies or any radio- or toxin- immunoconjugates) before the first study drug administration and have not recovered (to AEs \< Grade 2) from the toxic effects from any prior therapy * Subjects having received any other investigational agents within 4 weeks prior to the first study drug administration and have not recovered completely (to AEs \< Grade 2) from the side effects of the earlier investigational agent * Subjects with documented history of diabetes mellitus except for the Diabetes Expansion Cohort * For the Diabetes Expansion Cohort - Subjects who have type 1 diabetes mellitus, maturity onset diabetes of the young, hyperglycemia due to reasons other than type 2 diabetes mellitus. * For the Diabetes Expansion Cohort - Subjects who currently require insulin, thiazolidinediones, dual proliferator-activated receptors (PPAR) agonists, glucagon-like peptide (GLP-1) analogues, dipeptidyl peptidase (DPP-IV) inhibitors or have received the same in the 4 weeks prior to screening. * Subjects with known complications of diabetes like diabetic nephropathy or diabetic retinopathy * Subjects with known brain metastases * Subjects with gastrointestinal abnormalities including inability to take oral medication, malabsorption or other conditions like chronic inflammatory bowel disease that may affect absorption. * Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months * Subjects with baseline QTc interval \>470 msec at screening * Subjects on warfarin. Prophylactic anticoagulation with low molecular weight heparin is allowed * Subjects with history of anaphylaxis or angioedema, bronchial asthma, peptic ulcer and clinically significant food or drug allergy * Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Women who are pregnant or nursing * Subjects with known seropositivity to human immunodeficiency virus (HIV), positive for Hepatitis B, positive for Hepatitis C (antigen positive), or known hepatic cirrhosis