Pancreatic Cancer
Conditions
Keywords
Antibody, Pancreas, Carcinoma, Cancer, Pancreatic
Brief summary
This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.
Interventions
DRUGVolociximab
Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.
DRUGGemcitabine
Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, 18 years of age or older. * Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. * May have received prior immunotherapy (including monoclonal antibodies) or vaccine therapies. * Measurable disease, according to RECIST criteria. * Negative pregnancy test (women of childbearing potential only). * Pretreatment laboratory levels that meet specific criteria.
Exclusion criteria
* Prior treatment with Volociximab (M200) or inhibitors of α5β1 integrin (antibodies or small molecules) or gemcitabine and other chemotherapeutic regimens. * Known hypersensitivity to murine proteins or chimeric antibodies or other components of the product. * Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer). * Monoclonal antibody therapy within 4 weeks of the first dose of Volociximab. * Central Nervous System (CNS) tumor or metastasis. * History of bleeding disorders within the past year. * Medical conditions that may be exacerbated by bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients, in each dose cohort, with a confirmed tumor response | Any time during the course of the trial (up to 104 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the immunogenicity of M200 | During the course of the trial (up to 104 weeks) |
| Duration of progression-free survival | During the course of the trial (up to 104 weeks) |
| To evaluate the pharmacokinetics of M200 | During the course of the trial (up to 104 weeks) |
| Duration of overall survival | During the course of the trial (up to 104 weeks) |
| To evaluate the safety in of M200 in combination with gemcitabine | During the course of the trial (up to 104 weeks) |
| Time to disease progression | During the course of the trial (up to 104 weeks) |
Countries
United Kingdom, United States
Outcome results
None listed