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A Phase 1 Study of CNTO 888, a Human Monoclonal Antibody Against CC-Chemokine Ligand 2 in Subjects With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Phase 1 Study of CNTO 888, a Human Monoclonal Antibody Against CC-Chemokine Ligand 2 in Subjects With Solid Tumors


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.


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Principal Investigator

Centocor, Inc. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Centocor, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

CR013699

NCT ID:

NCT00537368

Start Date:

September 2007

Completion Date:

March 2010

Related Keywords:

  • Cancer
  • infusion
  • CNTO 888
  • Phase 1
  • solid tumor
  • cancer

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