An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: MORAb-009; Placebo; Gemcitabine
Intervention description: Monoclonal antibody administered once weekly by intravenous injection.; As per package insert.; Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.