| Exclusion Criteria: | 1) Patient who has had chemotherapy, radiotherapy with wide field radiation, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C), prior to entering the study or who has not recovered from adverse events due to agents administered more than 4 weeks prior to Study Cycle 1 Day 1. If the patient has residual toxicity from prior treatment, toxicity must be </= Grade 1. Radiotherapy with a limited field of radiation within 2 weeks of the first dose of treatment is permitted for palliative purposes.
2) Patient is currently participating or has participated in a study with an investigational compound or device within 30 days, or 5 times the half-life, from prior agents, whichever is longer, of Study Cycle 1 Day 1.
3) Patients with known central nervous system (CNS) metastases and/or carcinomatous meningitis are excluded. However, patients with CNS metastases who have completed a course of therapy are eligible for the study provided they are asymptomatic for 3 months prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids and anti-epileptic therapy.
4) Patient with a known primary central nervous system tumor or spinal cord compression.
5) Patient has known hypersensitivity to the components of study drug(s) or its analogs.
6) Patient has a previous or current condition, therapy, or laboratory abnormality that may confound the results of the study, interfere with the patient's participation for the full duration of the study, or increase the risk to the patient such that participation is not in his/her best interest, at the discretion of the investigator.
7) Patient has known psychiatric or substance abuse disorders that would interfere with compliance with study requirements.
8) Patient is, at the time of signing informed consent, a regular user (including recreational use) of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse.
9) Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
10) Patient is known to be Human Immunodeficiency Virus (HIV)-positive.
11) Patient has a known history of Hepatitis B or C, or active hepatitis A.
12) Patient has symptomatic (>/= Grade 2) ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible.
13) Patients must be at least 4 weeks post major surgery.
14) Patient has a history or current evidence of heart disease including: a) congestive heart failure New York Heart Association (NYHA) class 2 or greater, b) unstable angina pectoris, c) cardiac arrhythmia including atrial fibrillation with atrial rate > 100 beats per minute, d) history or current evidence of a myocardial infarction during the last 6 months, and/or a current electrocardiogram (ECG) tracing that is abnormal in the opinion of the treating Investigator, e) QTc prolongation >450 millisecond (msec) (Bazett's Formula)
15) (Continued from # 13) f) congenitally long QT syndrome, and/or current anti-arrhythmic therapy, has received any marketed or experimental compound in the last 4 weeks prior to entering the study with possible or known effects of QT prolongation, or cumulative high-dose anthracycline therapy, g) Left ventricular ejection fraction </= 50%.
16) Patient with evidence of clinically significant bradycardia (heart rate <50), or a history of clinically significant bradyarrhythmias such as sick sinus syndrome, 2nd degree atrioventricular (AV) block (Mobitz Type 2), or patients taking beta blockers, non-dihydropyridine calcium channel blockers, or digoxin.
17) Patient with uncontrolled hypertension [i.e., >/= 150/95 millimeters of mercury (mHg) sitting blood pressure (SiBP)]. Patients who are controlled on antihypertensive medication will be allowed to enter the study.
18) Patient at significant risk for hypokalemia (e.g., patients on high dose diuretics, or with recurrent diarrhea)
19) Patient with poorly controlled diabetic conditions [glycated hemoglobin (HBA1C) >8%]
20) Patient with refractory nausea and/or vomiting, chronic gastrointestinal disease (e.g.inflammatory bowel disease) or significant bowel resection of other condition which in the condition of the investigator could interfere with absorption of study medication. |