- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00537368
First Study of the Safety of CNTO 888 in Patients With Solid Tumors
October 21, 2010 updated by: Centocor, Inc.
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
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.
|
Secondary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
September 28, 2007
First Submitted That Met QC Criteria
September 28, 2007
First Posted (Estimate)
October 1, 2007
Study Record Updates
Last Update Posted (Estimate)
October 22, 2010
Last Update Submitted That Met QC Criteria
October 21, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CR013699
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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