CancerPhase 1NCT00537368
First Study of the Safety of CNTO 888 in Patients With Solid Tumors
A Phase 1 study testing CNTO 888 in people with Cancer, run by Centocor, Inc..
Trial summary
The purpose of this study is to determine if CNTO 888 is safe and to determine how long CNTO 888 stays in the body and what effects it might have on cancer tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- CNTO 888
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Mar 2010
- Phase
- Phase 1
- 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
- Patients with solid tumors that have progressed on or after all available standard therapy
- Histological or cytological documentation of specific tumor type
- Evidence of measurable or evaluable metastatic disease
- Anticipated life expectancy is >= 12 weeks
Who cannot join
- Treatment with systemic cancer therapy or local radiotherapy within 4 weeks
- Received any investigational drug/agent within 4 weeks
- Major surgery within 4 weeks of first dose of study agent
- Serious concurrent illness (medical or psychiatric), altered mental status (eg, dementia) or any uncontrolled medical condition (eg, uncontrolled diabetes).
About this study
Official title: A Phase 1 Study of CNTO 888, a Human Monoclonal Antibody Against CC-Chemokine Ligand 2 in Subjects With Solid Tumors
The purpose of this study is to determine if CNTO 888 is safe and to determine how long CNTO 888 stays in the body and what effects it might have on cancer tumors.
Read the detailed description
CNTO 888 is a monoclonal antibody. Antibodies are substances in the body that are involved in many biological processes. CNTO 888 is thought to work by blocking a protein called CC-Chemokine Ligand 2 (CCL2). In research studies CCL2 has been shown to increase the growth of new blood vessels which help the tumor to survive. When new blood vessels do not grow, tumors cannot get the food or oxygen they need to grow. Blocking CCL2 may help fight disease.This study consists of two parts, Part A and Part B. In Part A, five different groups of patients will be treated with five different, increasing dose levels of CNTO 888. In Part B, two of the dose levels of CNTO 888 will be tested further in different treatment schedules. CNTO 888 is given by intravenous (into the vein) infusion. Between 1 and 30 patients with advanced cancer will take part in Part A of the study. Between 24 and 33 patients with advanced cancer will take part in Part B of the study.There are three phases in part A of the study. Screening phase, which may last up to 4 weeks. Treatment phase, which may last up to 8 weeks (4 treatments) and can be extended for an extra 9 weeks (4 extra treatments) in case the patient's tumor is not getting bigger. The total treatment period could be up to 17 weeks. Follow up phase will include an end of treatment visit 4 weeks after the last infusion of CNTO 888, visits through week 18 after last infusion as well as long term collection of follow up data. After Part A is completed, up to two doses will be selected for evaluation in part B. In Part B, patients will be placed into one of 3 study groups. There are three phases in Part B of this study. The screening phase, which may last up to 4 weeks. The treatment phase, which may last up to 9 weeks (4 treatments). If the patient's tumor is not getting bigger, the patient's treatment phase may be extended up to 12 weeks (4 treatments). The total treatment period could be up to 21 weeks. The follow up phase will include an end of treatment visit 4 weeks after the last infusion of CNTO 888, visits through week 18 after last infusion as well as long-term collection of follow up data. Safety and effectiveness evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and collection of information about the occurrence and severity of adverse events. In Part A of this study, patients will receive either 0.3 , 1.0, 3.0, 10, or 15 mg/kg CNTO 888. The time between the first and second infusion is 4 weeks, with all of the following infusions will be given 2 weeks apart. Patients eligible for Part B will be assigned to either the lower dose selected from Part A, given every 2 weeks or the higher dose selected from Part A given either every 2 weeks or every 3 weeks. All patients may be in the study for 18 weeks after their last infusion.
- Conditions
- Cancer
- Being tested
- CNTO 888
- Keywords
- infusion, CNTO 888, Phase 1, solid tumor, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO 888Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and pharmacokinetics (rate of movement in the body and then the clearance) of CNTO 888 administered as multiple intravenous (IV) infusions in patients with solid tumors throughout the course of the study.
Secondary outcomes (1)
Assess the pharmacodynamics (action of drug on body systems), immune response and clinical effects (tumor response and time to disease progression) of CNTO888 when administered as multiple IV infusions in patients with solid tumors throughout the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startSep 2007
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537368
- Sponsor's protocol ID
- CR013699
- Status last verified
- Oct 2010
- First submitted
- 28 Sep 2007
- Last updated
- 22 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of CNTO 888, a Human Monoclonal Antibody Against CC-Chemokine Ligand 2 in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT00537368
- Acronym / sponsor ID
- CR013699
- Conditions
- Cancer
- Keywords
- infusion, CNTO 888, Phase 1, solid tumor, cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Study completion
- Mar 2010 (actual)
- First posted
- 1 Oct 2007 (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.
The purpose of this study is to determine if CNTO 888 is safe and to determine how long CNTO 888 stays in the body and what effects it might have on cancer tumors.
Detailed description
CNTO 888 is a monoclonal antibody. Antibodies are substances in the body that are involved in many biological processes. CNTO 888 is thought to work by blocking a protein called CC-Chemokine Ligand 2 (CCL2). In research studies CCL2 has been shown to increase the growth of new blood vessels which help the tumor to survive. When new blood vessels do not grow, tumors cannot get the food or oxygen they need to grow. Blocking CCL2 may help fight disease.This study consists of two parts, Part A and Part B. In Part A, five different groups of patients will be treated with five different, increasing dose levels of CNTO 888. In Part B, two of the dose levels of CNTO 888 will be tested further in different treatment schedules. CNTO 888 is given by intravenous (into the vein) infusion. Between 1 and 30 patients with advanced cancer will take part in Part A of the study. Between 24 and 33 patients with advanced cancer will take part in Part B of the study.There are three phases in part A of the study. Screening phase, which may last up to 4 weeks. Treatment phase, which may last up to 8 weeks (4 treatments) and can be extended for an extra 9 weeks (4 extra treatments) in case the patient's tumor is not getting bigger. The total treatment period could be up to 17 weeks. Follow up phase will include an end of treatment visit 4 weeks after the last infusion of CNTO 888, visits through week 18 after last infusion as well as long term collection of follow up data. After Part A is completed, up to two doses will be selected for evaluation in part B. In Part B, patients will be placed into one of 3 study groups. There are three phases in Part B of this study. The screening phase, which may last up to 4 weeks. The treatment phase, which may last up to 9 weeks (4 treatments). If the patient's tumor is not getting bigger, the patient's treatment phase may be extended up to 12 weeks (4 treatments). The total treatment period could be up to 21 weeks. The follow up phase will include an end of treatment visit 4 weeks after the last infusion of CNTO 888, visits through week 18 after last infusion as well as long-term collection of follow up data. Safety and effectiveness evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and collection of information about the occurrence and severity of adverse events. In Part A of this study, patients will receive either 0.3 , 1.0, 3.0, 10, or 15 mg/kg CNTO 888. The time between the first and second infusion is 4 weeks, with all of the following infusions will be given 2 weeks apart. Patients eligible for Part B will be assigned to either the lower dose selected from Part A, given every 2 weeks or the higher dose selected from Part A given either every 2 weeks or every 3 weeks. All patients may be in the study for 18 weeks after their last infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with solid tumors that have progressed on or after all available standard therapy
- Histological or cytological documentation of specific tumor type
- Evidence of measurable or evaluable metastatic disease
- Anticipated life expectancy is >= 12 weeks
Key exclusion criteria (4 listed)
- Treatment with systemic cancer therapy or local radiotherapy within 4 weeks
- Received any investigational drug/agent within 4 weeks
- Major surgery within 4 weeks of first dose of study agent
- Serious concurrent illness (medical or psychiatric), altered mental status (eg, dementia) or any uncontrolled medical condition (eg, uncontrolled diabetes).
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 |
|---|---|---|
| CNTO 888 | Drug | – |
Primary outcome
Evaluate the safety and pharmacokinetics (rate of movement in the body and then the clearance) of CNTO 888 administered as multiple intravenous (IV) infusions in patients with solid tumors throughout the course of the study.
1 secondary outcome
Assess the pharmacodynamics (action of drug on body systems), immune response and clinical effects (tumor response and time to disease progression) of CNTO888 when administered as multiple IV infusions in patients with solid tumors throughout the study.
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 22 Oct 2010.
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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.
Centocor, Inc. Clinical Trial study director
Centocor, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CNTO 888 in people with Cancer, run by Centocor, Inc..
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 4 inclusion and 4 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 22 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evaluate the safety and pharmacokinetics (rate of movement in the body and then the clearance) of CNTO 888 administered as multiple intravenous (IV) infusions in patients with solid tumors throughout the course of 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 22 Oct 2010.