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

Pancreatic Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570713
• Other study ID #: MORAb-009-002
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2007
• Last updated: September 4, 2015
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: September 2015
• Source: Morphotek
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• MORAb-009
Monoclonal antibody administered once weekly by intravenous injection.
• Placebo
As per package insert.
• 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.

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Jolimont-Lobbes	Haine Saint Paul	Hainaut
Belgium	Services de gastro-entérologie et d'oncologie, CHC Saint-Joseph	Liege
Belgium	AZ Sint Maarten - digestive oncology unit - campus	Mechelen
Canada	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia
Canada	London Regional Cancer Program London Health Sciences Centre	London	Ontario
Canada	Jewish General Hospital - Montreal	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
Germany	Charité, Universitätsmedizin Berlin	Berlin
Germany	Stadtische Kliniken Bielefeld-Mitte, Klinik fur Hamatologie und Onkologie	Bielefeld	Nordrhein-Westfalen
Germany	Klinik fuer Tumorbiologie an der Albert-Ludwigs-Universität Freiburg	Freiburg	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	II. Medizinische Klinik des Klinikums rechts der Isar	München	Bayern
Germany	Universitätsklinikum Ulm, Innere Medizin I	Ulm	Baden Wurttemburg
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	Hospital Clinico Universitario San Carlos	Madrid
Spain	Hospital Madrid	Madrid
United States	Arlington Cancer Center	Arlington	Texas
United States	Palm Beach Institute of Hematology and Oncology	Boynton Beach	Florida
United States	Gabrail Cancer Center	Canton	Ohio
United States	The Center for Cancer and Hematologic Disease	Cherry Hill	New Jersey
United States	South Carolina Oncology Associates, PA	Columbia	South Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida
United States	Moores UCSD Cancer Center	La Jolla	California
United States	Providence Western Washington Oncology	Lacey	Washington
United States	Arena Oncology Associates, P.C.	Lake Success	New York
United States	Hematology Oncology Associates of the Palm Beaches	Lake Worth	Florida
United States	Jayne Gurtler, MD, Laura Brinz, MD, & Angelo Russo, MD	Metairie	Louisiana
United States	Medical College of Wisconsin Clinical Cancer Center	Milwaukee	Wisconsin
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	South Texas Onocology Hemotology, PA	San Antonio	Texas
United States	Sharp Memorial Hospital	San Diego	California
United States	Southern California Permanente Medical Group	San Diego	California
United States	Hematology-Oncology Associates of Illinois, LLC	Skokie	Illinois
United States	Providence Cancer Center, Oncology, Clinical Trials	Southfield	Michigan
United States	Cancer Center of Central Connecticut	Southington	Connecticut
United States	Connecticut Oncology & Hematology	Torrington	Connecticut
United States	Carle Clinic Assoc.	Urbana	Illinois
United States	Kaiser Permanente	Vallejo	California
United States	University of Kansas Medical Center	Westwood	Kansas
United States	Hanover Medical Specialists, MD	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Morphotek

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Progression-free Survival	Progression-free Survival (PFS) is defined as the time from the date of randomization to the date of the first observation of disease progression (clinical or radiological) or death due to any cause. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. If progression or death is not observed, the PFS time will be censored at the date of the last tumor assessment without evidence of progression prior to the date of initiation of further anticancer treatment.	1-21 Months	No
Secondary	Best Overall Response Rate	Best overall response is the number of participants with a Complete Response (CR) or Partial Response (PR), as classified by independent blinded review of the CT or MRI images, based on RECIST 1.0. A CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum longest diameter. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameters of target lesions or the appearance of one or more new lesions. Stable disease (SD) is neither CR, PR or PD.	Baseline to response up to 21 months	No