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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.

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

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.

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

10. Known hypersensitivity to a monoclonal antibody or biologic therapy.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Description:

This measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up.

Outcome Time Frame:

1-21 Months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

December 2009

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms



Baylor College of Medicine Houston, Texas  77030
University of Kansas Medical Center Kansas City, Kansas  66160-7353
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Southern California Permanente Medical Group Downey, California  90242
Arlington Cancer Center Arlington, Texas  76012
Baptist Cancer Institute - Jacksonville Jacksonville, Florida  32207
Moores UCSD Cancer Center La Jolla, California  92093-0658
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213
Sharp Memorial Hospital San Diego, California  92123
South Carolina Oncology Associates, PA Columbia, South Carolina  29210
The Center for Cancer and Hematologic Disease Cherry Hill, New Jersey  08003
Kaiser Permanente Sacramento, California  
Gabrail Cancer Center Canton, Ohio  44718
Palm Beach Institute of Hematology and Oncology Boynton Beach, Florida  33435
Cancer Center of Central Connecticut Southington, Connecticut  
Connecticut Oncology & Hematology Torrington, Connecticut  06790
Hematology Oncology Associates of the Palm Beaches Lake Worth, Florida  33461
Hematology-Oncology Associates of Illinois, LLC Skokie, Illinois  60076
Carle Clinic Assoc. Urbana, Illinois  61801
Jayne Gurtler, MD, Laura Brinz, MD, & Angelo Russo, MD Metairie, Louisiana  70006
Providence Cancer Center, Oncology, Clinical Trials Southfield, Michigan  48075
Arena Oncology Associates, P.C. Lake Success, New York  11042
Hanover Medical Specialists, MD Wilmington, North Carolina  28401
South Texas Onocology Hemotology, PA San Antonio, Texas  78229
Providence Western Washington Oncology Lacey, Washington  98503
Medical College of Wisconsin Clinical Cancer Center Milwaukee, Wisconsin  53226