Safety and Efficacy Study of Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Metastatic Pancreatic Cancer

Inclusion Criteria

• Patient has definitive histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (Islet cell neoplasms are excluded) that is measurable by Response Evaluation criteria for solid tumors (RECIST V1.0)
• Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic pancreatic cancer. Prior treatment with 5-fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
• Patient has a Karnofsky performance status (KPS) ≥ 70
• Initial diagnosis of metastatic disease must have occurred ≤ 6 weeks prior to starting Cycle 1 Day 1. NOTE: the clock for this time interval starts with the date of last evaluation confirming pancreatic metastatic disease (either biopsy or imaging results)
• Patients should be asymptomatic for jaundice prior to Cycle 1 Day 1. Significant or symptomatic amounts of ascites should be drained prior to Cycle 1 Day 1. Pain symptoms should be stable and should not require modifications in analgesic management prior to Cycle 1 Day 1
• Patient has adequate blood counts at screening (obtained ≤ 14 days prior to starting Cycle 1 Day 1):
• Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
• Platelet count ≥ 100, 000/mm^3 (100 × 10^9/L);
• Hemoglobin (Hgb) ≥ 9 g/dL
• Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days prior to starting Cycle 1 Day 1):
• Aspartate aminotransferase (SGOT) and alanine transaminase (SGPT) are ≤ 2.5 upper limit of normal (ULN) range, unless liver metastases are clearly present, then ≤ 5 × upper limit of normal (ULN) range is allowed
• Total bilirubin ≤ upper limit of normal range
• Serum creatinine within normal limits or calculated clearance ≥ 60 mL/min/1.73 m^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockcroft-Gault formula). For patients with a body mass index (BMI) > 30 kg/m^2, lean body weight should be used instead.
• The patient has acceptable coagulation studies (obtained ≤14 days prior to starting Cycle 1 Day 1) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (WNL) ±15%.
• The patient has no clinically significant abnormalities in urinalysis results (obtained ≤14 days prior to starting Cycle 1 Day 1).
• Male or non-pregnant and non-lactating female, and ≥ 18 years of age at the time of signing the informed consent document.
• If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative pregnancy test (e.g. serum β-subunit of human chorionic gonadotropin (β-hCG) documented prior to the first administration of study drug.
• If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product's
• Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to participation in any study-related activities.
• Able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria

• Patient has known brain metastases
• Patient has only locally advanced disease.
• Patient has a ≥ 20% decrease in serum albumin level between Screening visit and within 72 hours prior to Cycle 1 Day 1.
• History of malignancy in the last 5 years (including c