Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3

Inclusion Criteria

• At least ≥ 18 years of age (male or female) at the time of signing the informed consent form.
• ECOG performance status of 0 to 1.
• Patients with:

Phase 2 only:

• Advanced or metastatic NSCLC failing platinum-based therapy

Phase 3 only:

• Advanced or metastatic breast cancer, who have failed 65 years of age and receiving full chemotherapy dose intensity
• Life expectancy of 3 months or more.
• The following laboratory results assessed within 14 days prior to study drug administration:
• Hemoglobin >/= 9 g/dL independent of transfusion or growth factor support
• Absolute neutrophil count (ANC) >/= 1.5 x 10**9/L independent of growth factor support
• Serum total bilirubin 2.5 x ULN)
• Serum creatinine 1 year prior to first dose of study drug
• Phase 3 only: Received >/= 5 lines of cytotoxic chemotherapy for advanced or metastatic breast cancer (adjuvant chemotherapy will count as one line of chemotherapy, and any hormonal or biological, non conjugate therapy [e.g., trastuzumab] will not count as a line of therapy).
• Current use of strong cytochrome P450 (CYP) 3A4 inhibitors, within 3 days of the first administration of study drug, and 7 days after treatment with taxanes OR requires use of strong CYP3A4 inhibitors
• Received an investigational agent or tumor vaccine within 2 weeks before the first dose of study drug; patients must have recovered from toxicity of prior treatment and have no > Grade 1 CTCAE (v4.03) treatment emergent AEs.
• Receiving any concurrent anticancer therapies (except continued hormonal treatment).
• Received a prior bone marrow or stem cell transplant.
• Has a co-existing active infection or received systemic anti-infective treatment within 72 hours before the first dose of study drug.
• Prior radiation therapy within the 4 weeks before the first dose of study drug.
• Prior use of pegfilgrastim or filgrastim within 4 weeks before the first dose of study drug.
• Presence of any serious or uncontrolled illness including, but not limited to: uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, uncontrolled arterial thrombosis, symptomatic pulmonary embolism, or psychiatric illness that would limit compliance with study requirements, or any other conditions that would preclude the patient from study treatment as per the discretion of the Investigator.
• Significant cardiovascular history:
• History of myocardial infarction or ischemic heart disease within 1 year (within a window of up to 18 days less than 1 year) before first study drug administration;
• Uncontrolled arrhythmia;
• History of congenital QT prolongation;
• Electrocardiogram (ECG) findings consistent with active ischemic heart disease;
• New York Heart Association Class III or IV cardiac disease;
• Uncontrolled hypertension: blood pressure consistently >150 mm Hg systolic and > 100 mm Hg diastolic in spite of antihypertensive medication.
• History of hemorrhagic diarrhea, inflammatory bowel disease, or active uncontrolled peptic ulcer disease. (Concomitant therapy with ranitidine or its equivalent and/or omeprazole or its equivalent is acceptable). History of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility.
• Any other malignancy requiring active therapy.
• Known human immunodeficiency virus (HIV) seropositivity.
• Active Hepatitis B virus (HBV) infection which requires antiviral treatment. Patients with detectable Hepatitis B surface Antigen (HBsAg) may be eligible provided the patient has a negative viral load. Patients with a positive HBsAg must have a negative viral load before each chemotherapy administration. Hepatitis B surface antibody (anti HBs) without detectable HBsAg does NOT exclude patients from the study. Hepatitis C infection (Hepatitis C antibody reactive) which requires treatment also excludes patients from the stu