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
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
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
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of the study is to evaluate the safety of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens.
During treatment and up to 30 days after last study treatment
Centocor, Inc. Clinical Trial
United States: Food and Drug Administration
|Seattle, Washington 98195|
|Flint, Michigan 48532|