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



Status:Active, not recruiting
Conditions:Cancer, Cancer, Cancer, Endocrine, Gastrointestinal, Gastrointestinal, Digestive Disease
Therapuetic Areas:Endocrinology, Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/17/2019
Start Date:March 28, 2014
End Date:February 15, 2020

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A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma

The purpose of this study is to compare whether there is a delay or prevention of recurrence
or death in subjects 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: 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
We found this trial at
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185 Cambridge Street
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666 Elm Street
Buffalo, New York 14263
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Gainesville, Florida 32610
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1200 Moursund Street
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2220 Pierce Ave
Nashville, Tennessee 37232
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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500 S State St
Ann Arbor, Michigan 48109
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Atlanta, Georgia 30341
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Basking Ridge, New Jersey 07920
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Boca Raton, Florida 33486
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450 Brookline Ave
Boston, Massachusetts 2215
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Charlottesville, Virginia 22903
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Chattanooga, Tennessee 37404
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5841 S Maryland Ave
Chicago, Illinois 60637
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5053 Wooster Rd
Cincinnati, Ohio 45226
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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2049 E 100th St
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94 Old Short Hills Road
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500 S Preston St
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333 Cedar Street
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