Ganitumab in Locally Advanced Unresectable Adenocarcinma of the Pancreas

Conditions: ocally advanced adenocarcinoma of the pancreas
MedDRA version: 14.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-023978-39-GB

Lead Sponsor: Amgen Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Disease Related
Subjects must have histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is unresectable, per institutional practice
Radiologically measurable and/or non-measurable disease as defined by
RECIST version 1.1 Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Demographic
Men or women = 18 years of age
Ethical
Before any protocol specified procedure is performed, the appropriate approved written informed consent must be obtained by the subject or the subject’s legally acceptable representative
Laboratory
Adequate organ function as evidenced by the following laboratory studies within 14 days before randomization:
Hemoglobin = 9 g/dL
Absolute neutrophil count = 1.5 x 109/L
Platelet count = 100 x 109/L (and no platelet transfusion within 14 days prior to the performance of the platelet count)
Partial thromboplastin (aPTT or PTT) = 1.3 x upper limit of normal (ULN) and international normalization ratio (INR) = 1.5, unless subject is on anti-coagulation therapy. Subjects on therapeutic anti-coagulation are eligible if there is no bleeding and they are on a stable dose of anticoagulation therapy (eg, warfarin with an INR of 2 to 3 within 7 days before randomization)
Calculated creatinine clearance = 40 mL/minute calculated by Cockcroft-Gault formula
Amylase = 2.0 x ULN
Blood glucose level = 160 mg/dL (8.9 mmol/L). Subjects with a non-fasting blood glucose > 160 mg/dL (8.9 mmol/L) must have a fasting blood glucose = 160 mg/dL (8.9 mmol/L) in order to be eligible
Total bilirubin = 2.0 x ULN
Aspartate aminotransferase (AST) and alanine amino transferase
(ALT) = 2.5 x ULN
General
Plan to begin protocol specified therapy within 7 days of randomization
Plan to be treated on protocol specified therapy until disease progression, withdrawal of consent or intolerable toxicity
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 127
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

Disease Related
Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma,
sarcoma, etc), adenocarcinoma originating from biliary tree or
cystadenocarcinoma
Early (stage I) or metastatic (stage IV) disease
External biliary drain
Any prior or synchronous malignancy, except:
• Malignancy treated with curative intent and with no known active disease present for = 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated cervical carcinoma in situ without evidence of disease
• Prostatic intraepithelial neoplasia without evidence of prostate cancer
Other Medical Conditions
Documented myocardial infarction or unstable/uncontrolled cardiac disease (eg, unstable angina, congestive heart failure [New York Heart Association(NYHA) > Class II]) within 6 months before randomization
History of any medical condition that in the opinion of the investigator, may increase the risks associated with study participation or protocol specified therapy or may interfere with the conduct of the study or interpretation of study results
Major surgical procedure within 30 days before randomization or not yet recovered from prior major surgery. Major surgery is defined within this protocol as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy)
Minor surgical procedures within 7 days before randomization or not yet
recovered from prior minor surgery; although placement of central venous access device, fine needle aspiration or endoscopic biliary stent = 1 day before randomization is acceptable
Known positive test for human immunodeficiency virus or hepatitis C or acute or chronic hepatitis B infection
Any co-morbid disease that would increase the risk of toxicity
Medications or Other Treatments
Currently treated or previously treated with biologic, small molecule,
immunotherapy, chemotherapy (ie, including gemcitabine), or other agents for pancreatic cancer
Currently treated or previously treated with radiotherapy, or chemoradiotherapy for pancreatic cancer
Recent infection requiring a course of systemic anti-infectives that was
completed within 7 days before randomization (with the exception of
uncomplicated urinary tract infection)
General
Subject is continuing to receive other investigational agent(s) or subject has not yet completed at least 30 days (before randomization) since ending other investigational device or drug study(s)
Subject of child-bearing potential is evidently pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding
Woman or man with partner of childbearing potential not consenting to use adequate contraceptive precautions ie, double barrier contraceptive methods (eg diaphragm plus condom), or abstinence, during the course of protocol specified therapy and for 6 months after the last dose of protocol specified therapy for women and men (including sperm donation)
Subject has known sensitivity to any of the products to be administered during the study
Subject was previously randomized into this study
Subject will not be available for protocol required study visits or procedures, to the best of the subject and investigator’s knowledge
Subject has any kind of disorder that compromises the ability of the subject to give writt