Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

At least 18 years of age
Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
Histologically or cytologically confirmed advanced or metastatic solid malignancy
Advanced or metastatic solid malignancy previously treated with one or more regimens of chemotherapy or for which no effective therapy is available
Recovered from toxicities of prior therapy
Measurable disease by RECIST criteria (at least one target lesion)
ECOG performance status of 0 or 1
Life expectancy of at least 3 months

Acceptable liver function:

Bilirubin ≤ 1.5 times upper limit of normal
AST (SGOT) and ALT (SGPT) ≤ 2.5 times upper limit of normal (ULN); if liver metastases are present, then ≤ 5 x ULN is allowed

Acceptable renal function:

Serum creatinine ≤ ULN

Acceptable hematologic status (without hematologic support):

ANC ≥ 1500 cells/μL
Platelet count ≥ 100,000/μL
Hemoglobin ≥ 9.0 g/dL
Urinalysis: No clinically significant abnormalities

Acceptable coagulation status:

PT ≤ 1.3 x ULN
PTT ≤ 1.3 x ULN
All women of childbearing potential must have a negative serum pregnancy test and women and men subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose

Exclusion Criteria:

Prior treatment with high dose chemotherapy
Prior radiotherapy to more than 25% of the bone marrow
New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial infarction within 6 months prior to Day 1, or unstable arrhythmia
Seizure disorders requiring anticonvulsant therapy
Symptomatic brain metastases (unless previously treated and well controlled for a period of ≥ 3 months)
Severe chronic obstructive pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state leading to hypoxemia
Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Treatment with radiation therapy, surgery, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.) or hormones within 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C)
Patients who participated in an investigational drug or device study within 28 days prior to study entry
Known infection with HIV, hepatitis B, or hepatitis C
Patients who have exhibited allergic reactions to a similar structural compound, biological agent, or formulation (containing solutol and/or propylene glycol)
Females who are pregnant or breast-feeding
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Unwillingness or inability to comply with the study protocol for any reason