Pancreatic Cancer
Conditions
Keywords
GSI, Gilead, Gilead Sciences, Pancreatic Cancer, PC, Gemcitabine, Phase 2, Phase II, GS-6624, Oncology, Monoclonal Antibody
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 sequential parts: an open label treatment phase and a double-blinded treatment phase.
Interventions
DRUGSimtuzumab
Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
DRUGGemcitabine
Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
DRUGPlacebo to match simtuzumab
Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | Up to 3 years | Progression free survival is measured as time from date of randomization to the earliest event time of death regardless of cause or first indication of disease progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Up to 3 years | Overall survival is measured as time from date of randomization to death regardless of cause. |
| Objective response | Up to 3 years | Objective response is assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as complete response, partial response, stable disease, or progressive disease. |
Countries
Russia, United States
Outcome results
None listed