|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Male or female patients 18 years or older
- Eastern Cooperative Oncology Group performance status 0-2.
- A diagnosis of a nonhematologic malignancy for which standard treatment is no longer effective. In the expanded cohort, enrollment will be limited to patients with a diagnosis of NSCLC, head and neck cancer (squamous cell cancer), soft tissue sarcoma, or prostate cancer.
- Suitable venous access PK and pharmacodynamic evaluations
Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
Male patients who agree to to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
- Voluntary written consent must be obtained.
Adequate blood and chemistry values during the screening period:
- Absolute neutrophil count (ANC) ≥1,500/mm3; platelet count ≥100,000/mm3
- Total bilirubin must be ≤1.5 × the upper limit of the normal range upper limit of normal (ULN).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), must be ≤2.5 × the upper limit of normal (ULN). AST and ALT may be elevated up to 5 times the upper limit of normal if their elevation can be reasonably ascribed to the presence of metastatic disease.
- Calculated creatinine clearance ≥30 mL/minute
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Peripheral neuropathy ≥Grade 2
- Female patients who are lactating or have a positive serum pregnancy test during the screening period
- Major surgery within 14 days before the first dose of treatment
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before the first dose of study treatment
- Life-threatening illness unrelated to cancer
- Diarrhea >Grade 1 based on the NCI CTCAE categorization
- Systemic antineoplastic therapy / or radiotherapy within 21 days before the first dose of study treatment
- Systemic treatment with prohibited medications
- Patient has symptomatic brain metastasis.
- Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or myocardial infarction within the past 6 months
- QTc >470 milliseconds (msec) on a 12-lead electrocardiogram (ECG) obtained during the screening period.
- Known human immunodeficiency virus (HIV), hepatitis B and hepatitis C positive
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
- Treatment with any investigational products within 28 days before the first dose of study treatment