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Volociximab

Phase 2

Pancreatic Cancer | Monoclonal antibody | Oncology |AbbVie Inc.|Trials Updated: Jan 30, 2013

Volociximab development status

Highest phase Phase 2
Registered trials 3 across 3 sponsors since Aug 2006

Volociximab target and mechanism

Molecular targetITGB1, ITGA5
Target classAntagonist
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Volociximab clinical trials

Volociximab · 1 trial · 1 indication

Phase 2 1
NCT00401570A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic CancerPancreatic Cancer
COMPLETED40 Analytics
PHASE2COMPLETED
A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer
Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALVolociximab (10 mg/kg every other week (qowk)) and Gemcitabine
Cohort 2EXPERIMENTALVolociximab (15 mg/kg weekly (qwk)) and Gemcitabine

Interventions

NameTypeDescription
VolociximabDRUGVolociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.
GemcitabineDRUGGemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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. ...

Countries:United StatesUnited Kingdom
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Competitive Landscape -Pancreatic Cancer 248 trials

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Frequently asked questions about Volociximab

What is Volociximab used for?

Volociximab was studied for the treatment of metastatic pancreatic cancer. It was evaluated in combination with gemcitabine in a Phase 2 clinical trial in adults with this disease. Volociximab is an investigational monoclonal antibody and is not an approved therapy for pancreatic cancer or any other indication.

What does Volociximab target?

Volociximab targets the integrins ITGB1 and ITGA5. It acts as an antagonist, meaning it blocks rather than activates these targets. By binding ITGB1 and ITGA5, the antibody interferes with integrin-mediated signaling. This mechanism was the basis for studying volociximab in pancreatic cancer, where integrin activity is thought to support tumor growth and survival.

Who is developing Volociximab?

Volociximab was developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored the clinical research program for the drug, including the Phase 2 study in metastatic pancreatic cancer. The asset is an investigational monoclonal antibody in the oncology therapeutic area.

What phase is Volociximab in?

Volociximab is in Phase 2 development. It has not been approved by the FDA or any other regulatory agency and remains an investigational agent. Only one clinical trial has been conducted, and that study is now completed. No active trials of volociximab are currently listed.

What clinical trials is Volociximab in?

Volociximab was evaluated in one completed Phase 2 trial, NCT00401570, titled A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer. The trial enrolled 40 adults aged 18 years and older across the United States and the United Kingdom. It used a controlled design and was not randomized or double blinded.