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
67
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
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185 Cambridge Street
Boston, Massachusetts 02114
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330 Brookline Ave
Boston, Massachusetts 02215
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
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
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30341
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Aurora, Colorado 80045
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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
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Charlottesville, Virginia 22903
(434) 924-0311
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Chattanooga, Tennessee 37404
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Cleveland, Ohio 44106
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Cleveland, Ohio 44195
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Commack, New York 11725
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Dallas, Texas 75246
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Dallas, Texas 75246
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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Gainesville, Florida 32605
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500 Westchester Avenue
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La Jolla, California 92093
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Lake Success, New York 11042
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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500 S Preston St
Louisville, Kentucky
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University of Louisville The University of Louisville is a state supported research university located in...
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333 Cedar Street
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Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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630 W 168th St
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Niles, Illinois 60714
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8303 Dodge Street
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Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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1020 Walnut St
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Pittsburgh, Pennsylvania 15323
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