First Study of the Safety of CNTO 888 in Patients With Solid Tumors
A Phase 1 Study of CNTO 888, a Human Monoclonal Antibody Against CC-Chemokine Ligand 2 in Subjects With Solid Tumors
1 other identifier
interventional
44
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 cancer
Started Sep 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 28, 2007
CompletedFirst Posted
Study publicly available on registry
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedOctober 22, 2010
October 1, 2010
September 28, 2007
October 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 28, 2007
First Posted
October 1, 2007
Study Start
September 1, 2007
Study Completion
March 1, 2010
Last Updated
October 22, 2010
Record last verified: 2010-10