An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer



Status:Completed
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2007
End Date:December 2009

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A Phase 2 Randomized, Placebo-controlled, Double-blind Study of the Efficacy of MORAb-009 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer.

The purpose of this study is to investigate the activity of MORAb-009 when added to a
standard regimen of gemcitabine in patients with previously untreated unresectable stage 3
or 4 pancreatic cancer.


Inclusion Criteria:

1. Female or male subjects, ≥ 18 years of age, with cytologically or histologically
confirmed diagnosis of pancreatic adenocarcinoma.

2. Must have measurable disease, as defined by RECIST or evaluable by clinical
signs/symptoms (e.g. ascites, pleural effusion, or lesions of less than 2 cm)
supported by biomarker, radiologic, or pathologic studies conducted within 4 weeks
prior to study entry.

3. Must have unresectable disease and have received no prior chemotherapy or radiation
therapy for their pancreatic cancer.

4. Karnofsky performance status of greater than or equal to 70 %.

5. Female subjects of childbearing potential and all male subjects must be surgically
sterile or consent to use a medically acceptable method of contraception throughout
the study period.

6. Other significant medical conditions must be well-controlled and stable in the
opinion of the investigator for at least 30 days prior to Study Day 1.

7. Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin
≥ 9 g/dL Serum bilirubin ≤ 2.0 mg/dL Aspartate transaminase (AST)* ≤ 5 x upper limit
of normal (ULN) Alanine transaminase (ALT)* ≤ 5 x ULN Alkaline phosphatase* ≤ 5 x ULN
Serum creatinine ≤ 2.0 mg/dL Stenting to reduce liver functions to qualifying levels
is permitted.

* Subjects with liver function abnormalities greater than the ULN are eligible only
if in the opinion of the investigator they are due to disease obstruction of the bile
ducts or metastatic disease.

8. Must be willing and able to provide written informed consent.

Exclusion Criteria:

1. Known central nervous system (CNS) tumor involvement.

2. Evidence of other active malignancy requiring treatment.

3. Clinically significant heart disease (e.g., congestive heart failure of New York
Heart Association Class 3 or 4 angina not well controlled by medication, or
myocardial infarction within 6 months).

4. Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note:
Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal
supraventricular tachycardia [SVT], are eligible).

5. Active serious systemic disease, including active bacterial or fungal infection.

6. Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection.

7. Prior chemotherapy or radiation therapy for their pancreatic cancer.

8. Breast-feeding, pregnant, or likely to become pregnant during the study.

9. No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of
systemic corticosteroids with the exception that low-dose corticosteroids are
allowed)

10. Known hypersensitivity to a monoclonal antibody or biologic therapy.
We found this trial at
27
sites
2320 S Seacrest Blvd # 300
Boynton Beach, Florida 33435
1293
mi
from
Boynton Beach, FL
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166 Stoneridge Drive
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
968
mi
from
Columbia, SC
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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...
569
mi
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Houston, TX
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Arlington, Texas 76012
348
mi
from
Arlington, TX
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
900
mi
from
Canton, OH
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Cherry Hill, New Jersey 08003
1232
mi
from
Cherry Hill, NJ
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Haine Saint Paul, Hainaut
?
mi
from
Haine Saint Paul,
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800 Prudential Drive
Jacksonville, Florida 32207
904.202.2000
Baptist Cancer Institute - Jacksonville For more than 20 years, health care consumers have named...
1058
mi
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Jacksonville, FL
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La Jolla, California 92093
1142
mi
from
La Jolla, CA
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Lacey, Washington 98503
1418
mi
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Lacey, WA
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Lake Success, New York 11042
1303
mi
from
Lake Success, NY
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1288
mi
from
Lake Worth, FL
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693
mi
from
Metairie, LA
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636
mi
from
Milwaukee, WI
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
153
mi
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Oklahoma City, OK
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
974
mi
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Pittsburgh, PA
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San Antonio, Texas 78229
576
mi
from
San Antonio, TX
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7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
1139
mi
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San Diego, CA
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San Diego, California 92120
1136
mi
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San Diego, CA
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610
mi
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Skokie, IL
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836
mi
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Southfield, MI
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Southington, Connecticut 06489
1347
mi
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Southington, CT
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Torrington, Connecticut 06790
1337
mi
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Torrington, CT
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Urbana, Illinois 61801
541
mi
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Urbana, IL
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Vallejo, California 94589
1327
mi
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Vallejo, CA
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Westwood, Kansas 66205
195
mi
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Westwood, KS
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Wilmington, North Carolina 28401
1135
mi
from
Wilmington, NC
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