Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
The purpose of this study is to compare whether there is a delay or prevention of recurrence
 or death in participants with surgically removed pancreatic cancer who then take
 nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.
ABI-007-PANC-003 is a Phase 3, international, multicenter, randomized, open-label, controlled
 study that will compare the efficacy of nab-paclitaxel in combination with gemcitabine to
 gemcitabine alone as adjuvant treatment for 6 cycles in patients with surgically resected
 pancreatic adenocarcinoma.
Inclusion Criteria:

 1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic
 complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors
 are excluded.

 2. Pancreatic cancer surgical staging: Tumor (T) 1-3, Lymph Node (LN) N0-1, Metastasis
 (M) 0.

 3. Subject should be able to start treatment no later than 12 weeks postsurgery.

 4. ≥18 years of age at the time of signing the informed consent form (ICF).

 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

 6. Acceptable hematology parameters:

 -  Absolute neutrophil count (ANC) ≥1500 cell/mm^3

 -  Platelet count ≥100,000/mm^3

 -  Hemoglobin (Hgb) ≥9 g/dL

 7. Acceptable blood chemistry levels:

 -  Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT)
 and alanine transaminase (ALT)/ serum glutamic -pyruvic transaminase (SGPT) ≤2.5
 × upper limit of normal range (ULN)

 -  Total bilirubin ≤ upper limit of normal (participants with Gilbert's syndrome can
 have bilirubin of up to 1.5 x ULN)

 -  Alkaline phosphatase ≤ 2.5 x ULN

 -  Serum creatinine within upper limits of normal or calculated clearance ≥50
 mL/min/1.73 m^2. If using creatinine clearance, actual body weight should be used
 for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For
 subjects with a body mass index (BMI) >30 kg/m2, lean body weight should be used
 instead

 8. Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization

 9. Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial
 thromboplastin time (PTT) within normal limits (±15%)

 Exclusion Criteria:

 A subject will not be eligible for inclusion in this study if any of the following criteria
 apply:

 1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma

 2. Presence of or history of metastatic pancreatic adenocarcinoma

 3. Any other malignancy within 5 years prior to randomization, with the exception of
 adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin
 cancer (all treatment of which should have been completed 6 months prior to
 randomization)

 4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic
 therapy, defined as ongoing signs/symptoms related to the infection without
 improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment

 5. Known infection with hepatitis B or C, or history of human immunodeficiency virus
 (HIV) infection, or subject receiving immunosuppressive or myelosuppressive
 medications that would in the opinion of the investigator, increase the risk of
 serious neutropenic complications

 6. History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of
 their excipients

 7. Serious medical risk factors involving any of the major organ systems, or serious
 psychiatric disorders, which could compromise the subject's safety or the study data
 integrity. These include, but are not limited to:

 1. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)

 2. History of interstitial lung disease, slowly progressive dyspnea and unproductive
 cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary
 hypersensitivity pneumonitis or multiple allergies

 3. History of the following within 6 months prior to Cycle 1 Day 1: a myocardial
 infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass
 graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled
 hypertension, clinically significant cardiac dysrhythmia or electrocardiogram
 (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or
 seizure disorder