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
- Conditions
- Advanced pancreatic cancer in subject with unresectable disease who have received no prior chemotherapy or radiation therapy for pancreatic cancer.MedDRA version: 9.1Level: LLTClassification code 10033575Term: Pancreas cancer
- Registration Number
- EUCTR2007-007633-39-DE
- Lead Sponsor
- Morphotek, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 152
1.Female or male subjects, = 18 years of age, with pathologically confirmed diagnosis of pancreatic adenocarcinoma.
2.Must have measurable disease as defined by RECIST (see Appendix A). RECIST evaluation must have occurred within 4 weeks prior to study entry.
3.Must have newly diagnosed, unresectable disease and have received no prior chemotherapy, radiation therapy or surgery with curative intent for 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 and 2 months after the last dose of test article.
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 (14 days) 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 = 5 x ULN are eligible only if in the opinion of the investigator these elevations are due to disease obstruction of the bile ducts or metastatic disease.
8.Must be willing and able to provide written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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. Positive serology alone is not exclusionary.
7.Prior surgery with curative intent for pancreatic cancer.
8.Prior or current chemotherapy or radiation therapy for pancreatic cancer. Palliative radiation for distant metastases (excluding metastases in the abdominal region) is allowed.
9.Breast-feeding, pregnant, or likely to become pregnant during the study.
10.Other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids with the exception that low-dose corticosteroids are allowed)
11.Known hypersensitivity to a monoclonal antibody or biologic therapy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the effect on overall survival of adding MORAb-009 to gemcitabine in subjects with previously untreated unresectable pancreatic cancer.;Secondary Objective: To determine progression-free survival (PFS). <br>To assess changes in overall response rate (ORR).<br>To determine the changes of the Karnofsky performance status (KPS).<br>To determine safety of MORAb-009 when administered with gemcitabine.<br>;Primary end point(s): Overall Survival
- Secondary Outcome Measures
Name Time Method