Clinical trial NCT00401570: A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Antibody
Pancreas
Carcinoma
Cancer
Pancreatic
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The proportion of patients, in each dose cohort, with a confirmed tumor response
timeFrame: Any time during the course of the trial (up to 104 weeks)
Secondary outcomes:
measure: Duration of progression-free survival
timeFrame: During the course of the trial (up to 104 weeks)
measure: Time to disease progression
timeFrame: During the course of the trial (up to 104 weeks)
measure: Duration of overall survival
timeFrame: During the course of the trial (up to 104 weeks)
measure: To evaluate the safety in of M200 in combination with gemcitabine
timeFrame: During the course of the trial (up to 104 weeks)
measure: To evaluate the pharmacokinetics of M200
timeFrame: During the course of the trial (up to 104 weeks)
measure: To evaluate the immunogenicity of M200
timeFrame: During the course of the trial (up to 104 weeks)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Site Reference ID/Investigator# 70538
state: Pennsylvania
city: Nashville
country: United States
facility: Site Reference ID/Investigator# 70537
state: Tennessee
city: Glasgow
country: United Kingdom
facility: Site Reference ID/Investigator# 70534
city: Leeds
country: United Kingdom
facility: Site Reference ID/Investigator# 70533
city: Manchester
country: United Kingdom
facility: Site Reference ID/Investigator# 70536
city: Northwood
country: United Kingdom
facility: Site Reference ID/Investigator# 70535
Study officials:
affiliation: AbbVie
name: Mihail Obrocea, MD
role: STUDY_DIRECTOR
References: