Back to resultsAn Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MORAb-009
Placebo
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Moores UCSD Cancer Center
- Southern California Permanente Medical Group
- Sharp Memorial Hospital
- Kaiser Permanente
- Cancer Center of Central Connecticut
- Connecticut Oncology & Hematology
- Palm Beach Institute of Hematology and Oncology
- Baptist Cancer Institute - Jacksonville
- Hematology Oncology Associates of the Palm Beaches
- Hematology-Oncology Associates of Illinois, LLC
- Carle Clinic Assoc.
- University of Kansas Medical Center
- Jayne Gurtler, MD, Laura Brinz, MD, & Angelo Russo, MD
- Providence Cancer Center, Oncology, Clinical Trials
- The Center for Cancer and Hematologic Disease
- Arena Oncology Associates, P.C.
- Hanover Medical Specialists, MD
- Gabrail Cancer Center
- University of Oklahoma Health Sciences Center
- University of Pittsburgh Medical Center
- South Carolina Oncology Associates, PA
- Arlington Cancer Center
- Baylor College of Medicine
- South Texas Onocology Hemotology, PA
- Providence Western Washington Oncology
- Medical College of Wisconsin Clinical Cancer Center
- Centre Hospitalier Jolimont-Lobbes
- Services de gastro-entérologie et d'oncologie, CHC Saint-Joseph
- AZ Sint Maarten - digestive oncology unit - campus
- Queen Elizabeth II Health Sciences Center
- London Regional Cancer Program London Health Sciences Centre
- Princess Margaret Hospital
- Jewish General Hospital - Montreal
- Klinik fuer Tumorbiologie an der Albert-Ludwigs-Universität Freiburg
- Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Universitätsklinikum Heidelberg
- SLK-Kliniken Heilbronn GmbH, Medizinische Klinik III
- Universitätsklinikum Ulm, Innere Medizin I
- II. Medizinische Klinik des Klinikums rechts der Isar
- Stadtische Kliniken Bielefeld-Mitte, Klinik fur Hamatologie und Onkologie
- Charité, Universitätsmedizin Berlin
- Hospital Clinic i Provincial de Barcelona
- Hospital de la Santa Creu i Sant Pau
- Hospital Madrid
- Hospital Clinico Universitario San Carlos
- Hospital 12 de Octubre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MORAb-009
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00570713
Brief Title
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
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Morphotek
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MORAb-009
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MORAb-009
Intervention Description
Monoclonal antibody administered once weekly by intravenous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
As per package insert.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
1-21 Months
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
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.
Time Frame
1-21 Months
Title
Best Overall Response Rate
Description
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.
Time Frame
Baseline to response up to 21 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0845
Country
United States
Facility Name
Southern California Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permanente
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Cancer Center of Central Connecticut
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
Facility Name
Connecticut Oncology & Hematology
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Palm Beach Institute of Hematology and Oncology
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Baptist Cancer Institute - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Hematology Oncology Associates of the Palm Beaches
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Hematology-Oncology Associates of Illinois, LLC
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Carle Clinic Assoc.
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
University of Kansas Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Jayne Gurtler, MD, Laura Brinz, MD, & Angelo Russo, MD
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Providence Cancer Center, Oncology, Clinical Trials
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
The Center for Cancer and Hematologic Disease
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Arena Oncology Associates, P.C.
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Hanover Medical Specialists, MD
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
South Carolina Oncology Associates, PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
10595
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
South Texas Onocology Hemotology, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Providence Western Washington Oncology
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Facility Name
Medical College of Wisconsin Clinical Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Centre Hospitalier Jolimont-Lobbes
City
Haine Saint Paul
State/Province
Hainaut
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Services de gastro-entérologie et d'oncologie, CHC Saint-Joseph
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Sint Maarten - digestive oncology unit - campus
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
London Regional Cancer Program London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Jewish General Hospital - Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Klinik fuer Tumorbiologie an der Albert-Ludwigs-Universität Freiburg
City
Freiburg
State/Province
Baden Wurttemburg
ZIP/Postal Code
D 79106
Country
Germany
Facility Name
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden Wurttemburg
ZIP/Postal Code
D 69120
Country
Germany
Facility Name
SLK-Kliniken Heilbronn GmbH, Medizinische Klinik III
City
Heilbronn
State/Province
Baden Wurttemburg
ZIP/Postal Code
D 74078
Country
Germany
Facility Name
Universitätsklinikum Ulm, Innere Medizin I
City
Ulm
State/Province
Baden Wurttemburg
ZIP/Postal Code
D 89081
Country
Germany
Facility Name
II. Medizinische Klinik des Klinikums rechts der Isar
City
München
State/Province
Bayern
ZIP/Postal Code
D 81675
Country
Germany
Facility Name
Stadtische Kliniken Bielefeld-Mitte, Klinik fur Hamatologie und Onkologie
City
Bielefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
D 33604
Country
Germany
Facility Name
Charité, Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
D 13353
Country
Germany
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Facility Name
Hospital Madrid
City
Madrid
ZIP/Postal Code
28010
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer
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