Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to the completion of screening.
The presence of measurable metastatic pancreatic cancer documented by contrast enhanced CT (or MRI) scan in addition to 1 of the following:
1. Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR
2. Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either:
1. The presence of a mass in the pancreas OR
2. A history of resected pancreatic carcinoma
Measurable disease per RECIST (ver. 1.1)
ECOG Performance Status of 0 or 1.
Adequate hepatic, hematologic and renal functions.
You may not be if
A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas.
A diagnosis of pancreatic islet neoplasms.
Subject has undergone major surgery other than diagnosis surgery within 4 weeks of randomization
Presence of biliary obstruction requiring external drainage
Brain metastases.
Unstable cardiovascular function within the last 6 months of screening
Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis
Known HIV infection.
Uncontrolled hypertension at Screening
History or presence of any form of cancer, other than pancreatic cancer, within the 3 years prior to enrollment
Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed.
Uncontrolled systemic fungal, bacterial or viral infection
Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study
