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Sponsored by: |
Morphotek |
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Information provided by: | Morphotek |
ClinicalTrials.gov Identifier: | NCT00570713 |
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 |
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Pancreatic Cancer |
Drug: MORAb-009 Drug: Gemcitabine |
Phase II |
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. |
Estimated Enrollment: | 152 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | March 2010 |
Arms | Assigned Interventions |
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1: Experimental
Gemcitabine + MORAb-009
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Drug: MORAb-009
Monoclonal antibody administered once weekly by intravenous injection.
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2: Active Comparator
Gemcitabine
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Drug: Gemcitabine
As per package insert.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
Contact: Susan C. Weil, MD | 610-423-6182 | weil@morphotek.com |
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 |
Antibodies, Monoclonal Antibodies Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases |
Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Immunoglobulins Endocrine Gland Neoplasms |
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 |