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An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer
This study is currently recruiting participants.
Verified by Morphotek, October 2008
Sponsored by: Morphotek
Information provided by: Morphotek
ClinicalTrials.gov Identifier: NCT00570713
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: MORAb-009
Drug: Gemcitabine
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: 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.

Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Overall survival [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival; Overall response based on RECIST criteria; Change in Karnofsky Performance Status (KPS) [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 152
Study Start Date: December 2007
Estimated Study Completion Date: March 2010
Arms Assigned Interventions
1: Experimental
Gemcitabine + MORAb-009
Drug: MORAb-009
Monoclonal antibody administered once weekly by intravenous injection.
2: Active Comparator
Gemcitabine
Drug: Gemcitabine
As per package insert.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570713

Contacts
Contact: Susan C. Weil, MD 610-423-6182 weil@morphotek.com

  Show 29 Study Locations
Sponsors and Collaborators
Morphotek
  More Information

Responsible Party: Morphotek ( Martin Phillips, MD )
Study ID Numbers: MORAb-009-002
Study First Received: December 7, 2007
Last Updated: October 6, 2008
ClinicalTrials.gov Identifier: NCT00570713  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Immunoglobulins
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 13, 2009