A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer

Study Overview
=================
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.

Official Title
-----------------
Phase 2 Open-Label Study of Volociximab (M200) in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer Not Previously Treated With Chemotherapy

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Volociximab
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine | Drug: Volociximab<br>* Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.<br>Drug: Gemcitabine<br>* Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment<br>|
| Experimental: Cohort 2<br>Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine | Drug: Volociximab<br>* Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.<br>Drug: Gemcitabine<br>* Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of progression-free survival |  | During the course of the trial (up to 104 weeks) | 
| Time to disease progression |  | 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) | 
| To evaluate the pharmacokinetics of M200 |  | During the course of the trial (up to 104 weeks) | 
| To evaluate the immunogenicity of M200 |  | During the course of the trial (up to 104 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibody, Pancreas, Carcinoma, Cancer, Pancreatic