- Solid tumor patient who was been histopathologically or cytologically documented.
- Advanced primary or recurrent solid tumors patient who has not responded to standard
therapy or no standard therapy is available.
- The patient has measurable or nonmeasurable lesions according to Response Evaluation
Criteria in Solid Tumors [RECIST].
- The patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS)
score of 0-1 at study entry.
- The patient is able to provide written informed consent.
- The patient is age 20 years or older.
- The patient has a life expectancy of > 3 months.
- The patient has adequate hematologic function, as defined by:
- An absolute neutrophil count (ANC) > 1500/mm3 or /µL
- A hemoglobin level > 10 g/dL
- A platelet count > 100,000/mm3 or /µL
- The patient has adequate hepatic function, as defined by:
- A total bilirubin level < 1.8 mg/dL
- Aspartate transaminase (AST) levels < 86 International Units/liter (IU/L)
- Alanine transaminase (ALT) levels ≤ 86 IU/L
- The patient has adequate renal function, as defined by:
- Serum creatinine level ≤ 1.5 mg/dL, or
- Calculated serum creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min
- The patient's urinary protein is 0 on dipstick or 1+ but patient does not have edema
nor serum albumin < lower level of normal [LLN].
- The patient has adequate coagulation function, as defined by international normalized
ratio (INR) ≤ 1.5.
- The patient agrees to use adequate contraception during the study period and for 12
weeks after the last dose of study treatment.
- The patient has had chemotherapy or therapeutic radiotherapy within 28 days (6 weeks
for nitrosoureas or mitomycin C) prior to entering the study or patient has ongoing
side effects ≥ Grade 2 due to agents administered more than 28 days earlier.
- The patient has obvious evidence of intratumor cavitation.
- The patient has undergone major surgery (eg, laparotomy, thoracotomy, removal of
organ[s]) within 28 days prior to study entry, or subcutaneous venous access device
placement within 7 days prior to study entry.
- The patient has a history of postoperative bleeding complications or wound
complications from a surgical procedure.
- The patient has elective or planned surgery to be conducted during the trial.
- The patient has documented and/or symptomatic brain or leptomeningeal metastases.
(Patients who are clinically stable [no symptoms during 4 weeks prior to the
enrollment] with an assessment that no further treatment [radiation, surgical
excision, and administration of steroids] is required, are permitted to enter the
- The patient has uncontrolled intercurrent illness including, but not limited to:
- Thrombotic or hemorrhagic disorders
- Hemoptysis (approximately one-half of a teaspoon)
- Ongoing or active infection requiring systemic antibiotic treatment
- Congestive heart failure (Class III or IV of the New York Heart Association
classification for heart disease)
- Angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
- Uncontrolled hypertension (systolic blood pressure > 150 mmHg, diastolic blood
pressure > 95 mm Hg)
- Cardiac arrhythmia requires treatment [National Cancer Institute Common Terminology
Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), Grade 3], or asymptomatic
sustained ventricular tachycardia)
- Peripheral neuropathy of any etiology ≥ Grade 2 (NCI-CTCAE v 3.0)
- The patient has participated in clinical studies of non-approved experimental agents
or procedures within 4 weeks prior to study entry for small molecules, or 8 weeks
prior to study entry for non-approved monoclonal antibodies.
- The patient, if female, is pregnant (confirmed by urine or serum pregnancy test) or