Pancreatic CancerPhase 2NCT00401570
A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer
A Phase 2 study testing Volociximab and Gemcitabine in people with Pancreatic Cancer, run by AbbVie (prior sponsor, Abbott) at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Volociximab and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2005to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United Kingdom4 sites
Site Reference ID/Investigator# 70534
Glasgow, G12 0YN
Site Reference ID/Investigator# 70533
Leeds, LS16 6QB
Site Reference ID/Investigator# 70536
Manchester, M20 4BX
Site Reference ID/Investigator# 70535
Northwood, HA6 2RN
United States2 sites
Site Reference ID/Investigator# 70537
Nashville, Tennessee, 37232-7415
Site Reference ID/Investigator# 70538
Pittsburgh, Pennsylvania, 15213
About this study
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
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Volociximab, Gemcitabine
- Keywords
- Antibody, Pancreas, Carcinoma, Cancer, Pancreatic
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolociximabDrug
Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.
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
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine Receives: Drug: Volociximab; Drug: Gemcitabine |
| Cohort 2 | Experimental | Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine Receives: Drug: Volociximab; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients, in each dose cohort, with a confirmed tumor response
Measured: Any time during the course of the trial (up to 104 weeks)
Secondary outcomes (6)
Duration of progression-free survival
Measured: During the course of the trial (up to 104 weeks)
Time to disease progression
Measured: During the course of the trial (up to 104 weeks)
Duration of overall survival
Measured: During the course of the trial (up to 104 weeks)
To evaluate the safety in of M200 in combination with gemcitabine
Measured: During the course of the trial (up to 104 weeks)
To evaluate the pharmacokinetics of M200
Measured: During the course of the trial (up to 104 weeks)
To evaluate the immunogenicity of M200
Measured: During the course of the trial (up to 104 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startMar 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mihail Obrocea, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401570
- Sponsor's protocol ID
- M200-1205
- Status last verified
- Jan 2013
- First submitted
- 16 Nov 2006
- Last updated
- 30 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00401570
- Acronym / sponsor ID
- M200-1205
- Conditions
- Pancreatic Cancer
- Keywords
- Antibody, Pancreas, Carcinoma, Cancer, Pancreatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 20 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Volociximab, Drug: GemcitabineVolociximab (10 mg/kg every other week (qowk)) and Gemcitabine |
| Cohort 2 | Experimental | Drug: Volociximab, Drug: GemcitabineVolociximab (15 mg/kg weekly (qwk)) and Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VolociximabVolociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks. | Drug | Cohort 1, Cohort 2 |
| GemcitabineGemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment | Drug | Cohort 1, Cohort 2 |
Primary outcome
The proportion of patients, in each dose cohort, with a confirmed tumor response
Time frame: Any time during the course of the trial (up to 104 weeks)
6 secondary outcomes
Duration of progression-free survival
Time frame: During the course of the trial (up to 104 weeks)
Time to disease progression
Time frame: During the course of the trial (up to 104 weeks)
Duration of overall survival
Time frame: During the course of the trial (up to 104 weeks)
To evaluate the safety in of M200 in combination with gemcitabine
Time frame: During the course of the trial (up to 104 weeks)
To evaluate the pharmacokinetics of M200
Time frame: During the course of the trial (up to 104 weeks)
To evaluate the immunogenicity of M200
Time frame: During the course of the trial (up to 104 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihail Obrocea, MD study director
AbbVie
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Volociximab and Gemcitabine in people with Pancreatic Cancer, run by AbbVie (prior sponsor, Abbott) at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients, in each dose cohort, with a confirmed tumor response (time frame: Any time during the course of the trial (up to 104 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2013.