Clinical trial NCT00570713: An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Morphotek
Sponsor class: INDUSTRY
First posted: 2007-12-11
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 1-21 Months
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 1-21 Months
measure: Best Overall Response Rate
timeFrame: Baseline to response up to 21 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: San Diego
country: United States
facility: Southern California Permanente Medical Group
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente
state: California
city: Southington
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Torrington
country: United States
facility: Connecticut Oncology & Hematology
state: Connecticut
city: Boynton Beach
country: United States
facility: Palm Beach Institute of Hematology and Oncology
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute - Jacksonville
state: Florida
city: Lake Worth
country: United States
facility: Hematology Oncology Associates of the Palm Beaches
state: Florida
city: Skokie
country: United States
facility: Hematology-Oncology Associates of Illinois, LLC
state: Illinois
city: Urbana
country: United States
facility: Carle Clinic Assoc.
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Metairie
country: United States
facility: Jayne Gurtler, MD, Laura Brinz, MD, & Angelo Russo, MD
state: Louisiana
city: Southfield
country: United States
facility: Providence Cancer Center, Oncology, Clinical Trials
state: Michigan
city: Cherry Hill
country: United States
facility: The Center for Cancer and Hematologic Disease
state: New Jersey
city: Lake Success
country: United States
facility: Arena Oncology Associates, P.C.
state: New York
city: Wilmington
country: United States
facility: Hanover Medical Specialists, MD
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Oncology Associates, PA
state: South Carolina
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: South Texas Onocology Hemotology, PA
state: Texas
city: Lacey
country: United States
facility: Providence Western Washington Oncology
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Clinical Cancer Center
state: Wisconsin
city: Haine Saint Paul
country: Belgium
facility: Centre Hospitalier Jolimont-Lobbes
state: Hainaut
city: Liege
country: Belgium
facility: Services de gastro-entérologie et d'oncologie, CHC Saint-Joseph
city: Mechelen
country: Belgium
facility: AZ Sint Maarten - digestive oncology unit - campus
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: London
country: Canada
facility: London Regional Cancer Program London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital - Montreal
state: Quebec
city: Freiburg
country: Germany
facility: Klinik fuer Tumorbiologie an der Albert-Ludwigs-Universität Freiburg
state: Baden Wurttemburg
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Universitätsklinikum Heidelberg
state: Baden Wurttemburg
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn GmbH, Medizinische Klinik III
state: Baden Wurttemburg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm, Innere Medizin I
state: Baden Wurttemburg
city: München
country: Germany
facility: II. Medizinische Klinik des Klinikums rechts der Isar
state: Bayern
city: Bielefeld
country: Germany
facility: Stadtische Kliniken Bielefeld-Mitte, Klinik fur Hamatologie und Onkologie
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charité, Universitätsmedizin Berlin
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Madrid
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
Study officials:
References: