Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Males / females, ≥ 18 years old, any race / ethnicity, who can provide written Informed Consent
Life expectancy ≥ 3 months
Pathologically confirmed solid tumor, locally advanced / metastatic, refractory after standard therapy, or for which no effective curative or surgical treatment options are available
Measurable disease on baseline imaging per RECIST 1.1 criteria
ECOG performance status ≤ 1
Liver function:
Bilirubin ≤ 1.5 X upper limit of normal
AST, SGOT, ALT, SGPT ≤ 2.5 X upper limit of normal, < 5 upper limit if there are liver metastases
Renal function:
Serum creatinine within normal limits
Hematologic status:
Absolute neutrophil count ≥ 1500 cells/mm3.
Platelet count ≥ 100,000/mm3.
Hemoglobin ≥ 9 g/dL
Coagulation status:
Coagulation Prothrombin time ≤ 1.5 X upper limit
Partial thromboplastin time ≤ 1.5 X upper limit
Males must agree to use condoms during sex to prevent spillage of semen for the duration of the study and for 3 months after the patient leaves the study
Females in the study must not be pregnant or breast feeding and not planning to become pregnant or breast feed for the duration of the study, and for at least three months after study completion
Women of childbearing potential must commit to using a double barrier method of contraception, an intrauterine device, or sexual abstinence for the duration of the study and for at least three months after study completion
Serum pregnancy test for women of child bearing potential must be negative at entry into study
Written voluntary informed consent: the patient is capable of complying with the requirements of the written Informed Consent Form and complying with protocol requirements

Exclusion Criteria:

History of significant disease that in the Investigator's opinion would put the patient at high risk on the trial
Cognitive impairment sufficient to render the patient incapable of giving informed consent
History of clinically significant psychiatric illness that would prevent the patient from providing a valid ICF and complying with protocol requirements
Unwillingness or inability to comply with procedures required in this protocol
History or presence of alcoholism or drug abuse within the past 2 years
Patients who have had a major surgical procedure within the past 6 weeks
History of HIV, hepatitis B, or hepatitis C
Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
Women of childbearing potential who are lactating, pregnant or there is the likelihood of becoming pregnant within the coming 12 months; a positive serum beta-human chorionic gonadotropin test at time of screening for entry into study
New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
Patients with a mean QTc interval greater than 480ms are excluded. Avoid concomitant administration of agents that prolong the QT interval, except at the discretion of the investigator. If advised, patients should discontinue the use of these agents at least 2 weeks before the study begins. No uncontrolled arrhythmias.
Patients currently receiving other investigational agents
Participation in a study of an investigational drug within 4 weeks prior to the planned first day of study drug administration
Patients who have undergone radiation within the past 4 weeks
Treatment with molecularly targeted agents within the past 3 weeks prior to planned first study drug administration. Patients who were receiving standard chemotherapy or experimental therapies must wait 4 weeks from their last dose prior to the planned first study drug administration. Patients treated with nitrosoureas or mitomycin C must wait 6 weeks from their last dose prior to the planned first study drug administration.
Patients with known brain metastases may be excluded from this study. However, patients may be eligible if scans show limited disease or repeat scans show stable disease in the opinion of the investigator and patients have no ill effect from the metastases.
Herbal supplements are prohibited 1 week prior to the planned first study drug administration, during the clinical study, and up to the time that the patient is discharged from the study
Patients who have been exposed to medications, herbal preparations, or foods known to be predominant Cytochrome P450 2C9, 2C19, 2D6, 3A4/5 substrates, strong inhibitors or inducers within 7 days of planned first study treatment day
Patients who in the opinion of the Investigator would not be able to provide reliable study data or be available for study follow-up