Renal Cell CarcinomaPhase 2NCT00100685
Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)
A Phase 2 study testing Volociximab (anti-α5β1 integrin monoclonal antibody) in people with Renal Cell Carcinoma and Metastases, run by Abbott at 3 sites in United States.
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) and 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
- Renal Cell Carcinoma, Metastases
- What is being tested?
- Volociximab (anti-α5β1 integrin monoclonal antibody)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2005to Dec 2007
- 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
- Males and females of at least 18 years of age with metastatic RCC of predominantly clear cell histology who have received 0 to 2 prior treatment regimens for metastatic disease.
- Measurable disease according to Response Criteria for Solid Tumors.
- Negative pregnancy test (women of childbearing potential only).
- Pretreatment laboratory levels that meet specific criteria.
- Signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations
- Patients must have failed at least one approved or investigational tyrosine kinase inhibitor (TKI).
Who cannot join
- Any of the following histologies of RCC: papillary, chromophobe, collecting duct, or unclassified.
- Known sensitivity 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).
- Systemic chemotherapy, immunotherapy, radiation therapy, or monoclonal antibody therapy within 4 weeks of M200 administration.
- Documented central nervous system (CNS) tumor or CNS metastasis.
- History of thromboembolic events and bleeding disorders within the past year.
- Medical conditions that may be exacerbated by bleeding.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Site Reference ID/Investigator# 70399
Cleveland, Ohio, 44195
Site Reference ID/Investigator# 70400
Los Angeles, California, 90095
Site Reference ID/Investigator# 70401
New York, New York, 10021
About this study
Official title: Phase 2 Open-Label Study of Volociximab (M200) in Patients With Metastatic Renal Cell Carcinoma
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) and is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.
- Conditions
- Renal Cell Carcinoma, Metastases
- Being tested
- Volociximab (anti-α5β1 integrin monoclonal antibody)
- Keywords
- Kidney, renal, cancer, carcinoma, cell, metastatic, metastatic renal cell carcinoma, RCC
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volociximab (anti-α5β1 integrin monoclonal antibody)Drug
Volociximab intravenously (Cohort 1: 10 mg/kg every other week or Cohort 2: 15 mg/kg once a week) for up to 104 weeks or until disease progression, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Volociximab administered intravenously at a dose of 10 mg/kg qowk Receives: Drug: Volociximab (anti-α5β1 integrin monoclonal antibody) |
| Arm 2 | Experimental | Volociximab administered intravenously at a dose of 15 mg/kg qwk Receives: Drug: Volociximab (anti-α5β1 integrin monoclonal antibody) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with a confirmed tumor response at any time during the study
Measured: Any time during the study
Secondary outcomes (4)
Time to disease progression
Measured: Up to 104 weeks
Duration of tumor response
Measured: Up to 104 weeks
Pharmacokinetics (PK) of M200
Measured: Day 0 through Study Termination
Immunogenicity
Measured: Day 0 through Study Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mihail Obrocea, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100685
- Sponsor's protocol ID
- M200-1204
- Status last verified
- Apr 2012
- First submitted
- 4 Jan 2005
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Open-Label Study of Volociximab (M200) in Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00100685
- Acronym / sponsor ID
- M200-1204
- Conditions
- Renal Cell Carcinoma, Metastases
- Keywords
- Kidney, renal, cancer, carcinoma, cell, metastatic, metastatic renal cell carcinoma, RCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 Jan 2005 (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) and 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
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)Volociximab administered intravenously at a dose of 10 mg/kg qowk |
| Arm 2 | Experimental | Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)Volociximab administered intravenously at a dose of 15 mg/kg qwk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females of at least 18 years of age with metastatic RCC of predominantly clear cell histology who have received 0 to 2 prior treatment regimens for metastatic disease.
- Measurable disease according to Response Criteria for Solid Tumors.
- Negative pregnancy test (women of childbearing potential only).
- Pretreatment laboratory levels that meet specific criteria.
- Signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations
Key exclusion criteria (7 listed)
- Any of the following histologies of RCC: papillary, chromophobe, collecting duct, or unclassified.
- Known sensitivity 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).
- Systemic chemotherapy, immunotherapy, radiation therapy, or monoclonal antibody therapy within 4 weeks of M200 administration.
- Documented central nervous system (CNS) tumor or CNS 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 |
|---|---|---|
| Volociximab (anti-α5β1 integrin monoclonal antibody)Volociximab intravenously (Cohort 1: 10 mg/kg every other week or Cohort 2: 15 mg/kg once a week) for up to 104 weeks or until disease progression, whichever occurs first. | Drug | Arm 1, Arm 2 |
Primary outcome
The proportion of patients with a confirmed tumor response at any time during the study
Time frame: Any time during the study
4 secondary outcomes
Time to disease progression
Time frame: Up to 104 weeks
Duration of tumor response
Time frame: Up to 104 weeks
Pharmacokinetics (PK) of M200
Time frame: Day 0 through Study Termination
Immunogenicity
Time frame: Day 0 through Study Termination
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
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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
Abbott
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Volociximab (anti-α5β1 integrin monoclonal antibody) in people with Renal Cell Carcinoma and Metastases, run by Abbott at 3 sites in United States.
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: stopped early, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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 was stopped early. Results are not available in the source record.
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 with a confirmed tumor response at any time during the study (time frame: Any time during the study). 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 27 Apr 2012.