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

NCT00570713 | Completed Phase 2 Results DMC

• 1 other identifier: MORAb-009-002
• Study Type: interventional
• Target: 155
• Locations: 5 countries
• Sites: 45

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  This measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up.

  1-21 Months

Secondary Outcomes (2)

• Progression-free Survival

  1-21 Months

• Best Overall Response Rate

  Baseline to response up to 21 months

Study Arms (2)

MORAb-009

EXPERIMENTAL

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.

Drug: MORAb-009; Drug: Gemcitabine

Placebo

ACTIVE COMPARATOR

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.

Drug: Placebo; Drug: Gemcitabine

Interventions

MORAb-009 DRUG

Monoclonal antibody administered once weekly by intravenous injection.

MORAb-009

Placebo DRUG

As per package insert.

Placebo

Gemcitabine 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.

MORAb-009; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male subjects, ≥ 18 years of age, with cytologically or histologically confirmed diagnosis of pancreatic adenocarcinoma.
• 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.
• Must have unresectable disease and have received no prior chemotherapy or radiation therapy for their pancreatic cancer.
• Karnofsky performance status of greater than or equal to 70 %.
• 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.
• 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.
• 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.
• Must be willing and able to provide written informed consent.

You may not qualify if:

• Known central nervous system (CNS) tumor involvement.
• Evidence of other active malignancy requiring treatment.
• 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).
• Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia \[SVT\], are eligible).
• Active serious systemic disease, including active bacterial or fungal infection.
• Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection.
• Prior chemotherapy or radiation therapy for their pancreatic cancer.
• Breast-feeding, pregnant, or likely to become pregnant during the study.
• No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids with the exception that low-dose corticosteroids are allowed)
• Known hypersensitivity to a monoclonal antibody or biologic therapy.

Sponsors & Collaborators

• Morphotek: lead

Study Sites (45)

Moores UCSD Cancer Center

La Jolla, California, 92037-0845, United States

Location

Southern California Permanente Medical Group

San Diego, California, 92108, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Kaiser Permanente

Vallejo, California, 94589, United States

Location

Cancer Center of Central Connecticut

Southington, Connecticut, 06489, United States

Location

Connecticut Oncology & Hematology

Torrington, Connecticut, 06790, United States

Location

Palm Beach Institute of Hematology and Oncology

Boynton Beach, Florida, 33435, United States

Location

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

Hematology Oncology Associates of the Palm Beaches

Lake Worth, Florida, 33461, United States

Location

Hematology-Oncology Associates of Illinois, LLC

Skokie, Illinois, 60076, United States

Location

Carle Clinic Assoc.

Urbana, Illinois, 61801, United States

Location

University of Kansas Medical Center

Westwood, Kansas, 66205, United States

Location

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

Metairie, Louisiana, 70006, United States

Location

Providence Cancer Center, Oncology, Clinical Trials

Southfield, Michigan, 48075, United States

Location

The Center for Cancer and Hematologic Disease

Cherry Hill, New Jersey, 08003, United States

Location

Arena Oncology Associates, P.C.

Lake Success, New York, 11042, United States

Location

Hanover Medical Specialists, MD

Wilmington, North Carolina, 28401, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

South Carolina Oncology Associates, PA

Columbia, South Carolina, 10595, United States

Location

Arlington Cancer Center

Arlington, Texas, 76012, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

South Texas Onocology Hemotology, PA

San Antonio, Texas, 78229, United States

Location

Providence Western Washington Oncology

Lacey, Washington, 98503, United States

Location

Medical College of Wisconsin Clinical Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Centre Hospitalier Jolimont-Lobbes

Haine-Saint-Paul, Hainaut, 7100, Belgium

Location

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

Liège, 4000, Belgium

Location

AZ Sint Maarten - digestive oncology unit - campus

Mechelen, 2800, Belgium

Location

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, B3H 1V7, Canada

Location

London Regional Cancer Program London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Jewish General Hospital - Montreal

Montreal, Quebec, H2W 1S6, Canada

Location

Klinik fuer Tumorbiologie an der Albert-Ludwigs-Universität Freiburg

Freiburg im Breisgau, Baden Wurttemburg, D 79106, Germany

Location

Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Universitätsklinikum Heidelberg

Heidelberg, Baden Wurttemburg, D 69120, Germany

Location

SLK-Kliniken Heilbronn GmbH, Medizinische Klinik III

Heilbronn, Baden Wurttemburg, D 74078, Germany

Location

Universitätsklinikum Ulm, Innere Medizin I

Ulm, Baden Wurttemburg, D 89081, Germany

Location

II. Medizinische Klinik des Klinikums rechts der Isar

München, Bavaria, D 81675, Germany

Location

Stadtische Kliniken Bielefeld-Mitte, Klinik fur Hamatologie und Onkologie

Bielefeld, North Rhine-Westphalia, D 33604, Germany

Location

Charité, Universitätsmedizin Berlin

Berlin, D 13353, Germany

Location

Hospital Madrid

Madrid, Madrid, 28010, Spain

Location

Hospital Clinico Universitario San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 8025, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

amatuximab; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Susan Weil, MD
• Organization: Morphotek, Inc.

sweil@morphotek.com

610-423-6182

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 11, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 9, 2015
• Results First Posted: March 27, 2012

Record last verified: 2015-09

Locations

BE (3); CA (4); ES (5); DE (7); US (26)