Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
≥ 18 years old with a histologically or cytologically documented, advanced solid tumor
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (without granulocyte colony-stimulating factor \[G-CSF\] support within 2 weeks of study day 1); platelet count ≥ 100.0 x 10\^9/L (without transfusion within 2 weeks of study day 1); and hemoglobin ≥ 9.0 g/dL (erythropoietic agents allowed)
At least a 14-day period from end of last dose of chemotherapy received
Any prior toxicity from prior chemotherapeutic treatment recovered to ≤ grade 1
You may not be if
Subject enrolled in another investigational device or drug trial, or is receiving other investigational agents
Hematological malignancies
Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.
History of seizure disorder
Myocardial infarction (MI) within 6 months of study day 1, unstable angina, congestive heart failure (CHF) with New York Heart Association (NYHA) \> class II, or uncontrolled hypertension
Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low dose for port maintenance allowed)
Specified concomitant medications
Serum creatinine \> 1.5 x upper limit of normal (ULN)
Elevated liver enzymes (AST/ALT) \> 2.5 x ULN, or \> 5.0 x ULN if secondary to liver metastases; alkaline phosphatase \> 2.5 x ULN or \> 5.0 x ULN if secondary to liver or bone metastases; total bilirubin \> 1.5 x ULN
Radiation therapy within 14 days of study day 1
Antibody therapy for the treatment of an underlying malignancy within 14 days of study day 1
Concurrent radiation therapy is not permitted throughout the course of the study
