Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)

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: T 1-3, N0-1, M0.

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 ≥1500 cell/mm3

- Platelet count ≥100,000/mm3

- 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 (ULN) (subjects 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 m2. 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 ECG abnormality,
cerebrovascular accident, transient ischemic attack, or seizure disorder