NCT00401570

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Timeline
Completed

Started Mar 2005

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 30, 2013

Status Verified

January 1, 2013

Enrollment Period

3.3 years

First QC Date

November 16, 2006

Last Update Submit

January 28, 2013

Conditions

Pancreatic Cancer

Keywords

AntibodyPancreasCarcinomaCancerPancreatic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Study Arms (2)

Cohort 1

EXPERIMENTAL

Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine

Drug: VolociximabDrug: Gemcitabine

Cohort 2

EXPERIMENTAL

Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine

Drug: VolociximabDrug: Gemcitabine

Interventions

VolociximabDRUG

Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.

Cohort 1Cohort 2
GemcitabineDRUG

Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Site Reference ID/Investigator# 70538

Pittsburgh, Pennsylvania, 15213, United States

Location

Site Reference ID/Investigator# 70537

Nashville, Tennessee, 37232-7415, United States

Location

Site Reference ID/Investigator# 70534

Glasgow, G12 0YN, United Kingdom

Location

Site Reference ID/Investigator# 70533

Leeds, LS16 6QB, United Kingdom

Location

Site Reference ID/Investigator# 70536

Manchester, M20 4BX, United Kingdom

Location

Site Reference ID/Investigator# 70535

Northwood, HA6 2RN, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsCarcinomaNeoplasms

Interventions

volociximabGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Mihail Obrocea, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 20, 2006

Study Start

March 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 30, 2013

Record last verified: 2013-01

Locations

US(2)GB(4)