Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma
Lead Sponsor:
Gilead Sciences
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 s...
Eligibility Criteria
Inclusion
- 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:
- Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR
- Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either:
- The presence of a mass in the pancreas OR
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01472198
Start Date
November 1 2011
End Date
February 1 2015
Last Update
March 10 2015
Active Locations (57)
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1
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States
2
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
3
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States
4
Comprehensive Blood and Cancer Center
Bakersfield, California, United States