metastatic adenocarcinoma of the pancreas MedDRA version: 12.1 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic MedDRA version: 12.1 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable
Conditions
Interventions
Product Name: AMG 479
Product Code: AMG 479
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: AMG 479
Concentration unit: mg/l milligram(s)/litre
Concentration type: up
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must have histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas (American Joint Committee on Cancer Stage IV); ECOG score of 0 or 1; Men or women = 18 years of age. 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: Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma, sarcoma, etc), adenocarcinoma originated from biliary tree or cystadenocarcinoma; currently treated or previously treated with biologic, small molecule, immunotherapy, chemotherapy (eg, gemcitabine), radiotherapy, chemoradiotherapy or other agents for pancreatic cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if the treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in combination with gemcitabine improves overall survival (OS) as compared with placebo in combination with gemcitabine in subjects with metastatic adenocarcinoma of the pancreas.;Secondary Objective: • To evaluate progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 • To evaluate the survival rate at 12-months, and at the timepoints of 3, 6, 9, 18, and 24 months • objective response rate, time to disease progression, duration of response, and disease control rate (partial response [PR] + complete response [CR] + stable disease [SD]) as per RECIST version 1.1 • subject incidence of adverse events, significant laboratory abnormalities, and immunogenicity • AMG 479 dose exposure, dose intensity, and pharmacokinetic (PK) parameters and to evaluate relationships between AMG 479 exposure measures and selected safety and efficacy measures • gemcitabine dose exposure, dose intensity in all subjects, and gemcitabine PK parameters in a subset of subjects See protocol for more details;Primary end point(s): Overall survival | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Portugal, Slovenia, Spain, Sweden, United Kingdom
Outcome results
None listed