An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer

NCT ID: NCT00570713

Last Updated: 2015-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-12-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MORAb-009

MORAb-009 plus gemcitabine ('MORAb-009'): MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. 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.

Group Type: EXPERIMENTAL

MORAb-009

Intervention Type: DRUG

Monoclonal antibody administered once weekly by intravenous injection.

Gemcitabine

Intervention Type: DRUG

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.

Placebo

Placebo plus gemcitabine ('Placebo') Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. 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.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

As per package insert.

Gemcitabine

Intervention Type: DRUG

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.

Interventions

MORAb-009

Monoclonal antibody administered once weekly by intravenous injection.

Intervention Type: DRUG

Placebo

As per package insert.

Intervention Type: DRUG

Gemcitabine

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 Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Morphotek

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Moores UCSD Cancer Center

La Jolla, California, United States

Southern California Permanente Medical Group

San Diego, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Kaiser Permanente

Vallejo, California, United States

Cancer Center of Central Connecticut

Southington, Connecticut, United States

Connecticut Oncology & Hematology

Torrington, Connecticut, United States

Palm Beach Institute of Hematology and Oncology

Boynton Beach, Florida, United States

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Hematology Oncology Associates of the Palm Beaches

Lake Worth, Florida, United States

Hematology-Oncology Associates of Illinois, LLC

Skokie, Illinois, United States

Carle Clinic Assoc.

Urbana, Illinois, United States

University of Kansas Medical Center

Westwood, Kansas, United States

Jayne Gurtler, MD, Laura Brinz, MD, & Angelo Russo, MD

Metairie, Louisiana, United States

Providence Cancer Center, Oncology, Clinical Trials

Southfield, Michigan, United States

The Center for Cancer and Hematologic Disease

Cherry Hill, New Jersey, United States

Arena Oncology Associates, P.C.

Lake Success, New York, United States

Hanover Medical Specialists, MD

Wilmington, North Carolina, United States

Gabrail Cancer Center

Canton, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

South Carolina Oncology Associates, PA

Columbia, South Carolina, United States

Arlington Cancer Center

Arlington, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

South Texas Onocology Hemotology, PA

San Antonio, Texas, United States

Providence Western Washington Oncology

Lacey, Washington, United States

Medical College of Wisconsin Clinical Cancer Center

Milwaukee, Wisconsin, United States

Centre Hospitalier Jolimont-Lobbes

Haine-Saint-Paul, Hainaut, Belgium

Services de gastro-entérologie et d'oncologie, CHC Saint-Joseph

Liège, , Belgium

AZ Sint Maarten - digestive oncology unit - campus

Mechelen, , Belgium

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

London Regional Cancer Program London Health Sciences Centre

London, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Jewish General Hospital - Montreal

Montreal, Quebec, Canada

Klinik fuer Tumorbiologie an der Albert-Ludwigs-Universität Freiburg

Freiburg im Breisgau, Baden Wurttemburg, Germany

Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Universitätsklinikum Heidelberg

Heidelberg, Baden Wurttemburg, Germany

SLK-Kliniken Heilbronn GmbH, Medizinische Klinik III

Heilbronn, Baden Wurttemburg, Germany

Universitätsklinikum Ulm, Innere Medizin I

Ulm, Baden Wurttemburg, Germany

II. Medizinische Klinik des Klinikums rechts der Isar

München, Bavaria, Germany

Stadtische Kliniken Bielefeld-Mitte, Klinik fur Hamatologie und Onkologie

Bielefeld, North Rhine-Westphalia, Germany

Charité, Universitätsmedizin Berlin

Berlin, , Germany

Hospital Madrid

Madrid, Madrid, Spain

Hospital Clinico Universitario San Carlos

Madrid, Madrid, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital 12 de Octubre

Madrid, , Spain

Countries

United States; Belgium; Canada; Germany; Spain

Other Identifiers

MORAb-009-002

Identifier Type: -

Identifier Source: org_study_id