A Study of the Safety and Efficacy of CNTO 888 in Combination With SoC (Standard of Care) Chemotherapy in Patients With Solid Tumors



Status:Archived
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:May 2010

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An Open-label, Multicenter, Phase 1b Study of CNTO 888 (an Anti-CCL 2 Monoclonal Antibody) in Combination With Chemotherapies for the Treatment of Subjects With Solid Tumors


The purpose of this study is to evaluate the safety and dose regimen of CNTO 888 when
administered to patients with solid tumors in combination with 4 standard of care
chemotherapy regimens.


CNTO 888 is an antibody that works 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. It is hoped that blocking CCL2 may help to control tumor
growth.

Patients will receive one of four treatments. A dose of 15 mg/kg CNTO 888 will be
administered once every 3 weeks in combination with either docetaxel, gemcitabine, or
paclitaxel-carboplatin in Treatment Arms 1, 2, and 3, respectively; and 10 mg/kg CNTO 888
will be administered once every 2 weeks with DOXIL® / Caelyx® (doxorubicin HCl liposome
injection) for intravenous infusion once every 4 weeks in Treatment Arm 4. The maximum time
that patients will be in the study is one year.

Safety assessments will be conducted throughout the course of the study. Safety assessments
include the monitoring of side effects,clinical laboratory tests (hematology, biochemistry,
and urinalysis), vital signs, and physical examinations. CNTO 888 will be administered IV
at 2 different doses (15 mg/kg or 10 mg/kg) dependant on the chemotherapy combination.
Combination therapy will be continued until disease progression, unacceptable toxicity, the
patient refuses further combination therapy, withdraws consent, or is treated for 1 year


We found this trial at
2
sites
Detroit, Michigan
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Detroit, MI
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Mountlake Terrace, Washington
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Mountlake Terrace, WA
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