A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies

Inclusion criteria

• Signed written informed consent
• ≥ 18 years of age
• Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
• Measurable disease as per RECIST Version 1.1 criteria.
• Adequate bone marrow reserve as demonstrated by

• Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L
• Platelet count ≥ 100 x 10⁹/L
• Hemoglobin (Hgb) ≥ 9 g/L
• Adequate liver function as demonstrated by

• Total bilirubin of ≤ 1.5 mg/dL or ≤ 2.0 mg/dL for subjects with liver metastasis
• Alanine aminotransferase (ALT)≤ 3 x upper limit of normal (ULN) or ≤ 5x ULN if liver metastasis is present
• ALP ≤ 3 x ULN or ≤ 5 x ULN if bone metastasis is present
• Adequate renal function as demonstrated by serum creatinine ≤ 1.5 x ULN, or 24-hr urine creatinine clearance calculation >60 mL/min
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Life expectancy of at least 3 months
• Subjects who are not currently taking prohibited medication
• Women must be postmenopausal (> 12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception

Exclusion criteria

• Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational agents
• Received investigational agents within 14 days or 5 half-lives of the first study dosing day, whichever is longer.
• Women of childbearing potential who are pregnant or breast feeding.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or psychiatric illness/social situations that would limit compliance with study requirements
• Significant or uncontrolled cardiovascular disease or bleeding disorder
• Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the investigator may interfere with oral drug absorption
• Subjects with a known history of allergy to paclitaxel. Subjects whose allergy was due to the IV solvent (such as Cremophor®) and not paclitaxel will be eligible for this study.