Español: Cáncer de páncreas avanzado en pacientes con enfermedad no extirpable que no han recibido quimioterapia o radioterapia previa para el cáncer de páncreas. Ingles : Advanced pancreatic cancer in subject with unresectable disease who have received no prior chemotherapy or radiation therapy for pancreatic cancer. MedDRA version: 9.1 Level: LLT Classification code 10033575 Term:
Conditions
Interventions
Product Code: MORAb-009
Pharmaceutical Form: Solution for infusion
Current Sponsor code: MORAb-009
Other descriptive name: Monoclonal antibody to Human
Sponsors
Morphotek, Inc.
Eligibility
Sex/Gender
All
Inclusion 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 (see Appendix B) 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 % (see Appendix D). 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. 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). To assess changes in overall response rate (ORR). To determine the changes of the Karnofsky performance status (KPS). To determine safety of MORAb-009 when administered with gemcitabine. ;Primary end point(s): Overall Survival | — |
Countries
Belgium, Germany, Spain
Outcome results
None listed