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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centocor, Inc.

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Cancer

Clinical Trials on CNTO 888

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings