NCT01204996

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection	10 mg/kg CNTO 888 every 2 weeks plus DOXIL®/Caelyx® (doxorubicin HCl liposome injection) 50 mg/m2 every 4 weeks
DRUG	CNTO888 + gemcitabine	15 mg/kg CNTO 888 every 3 weeks plus gemcitabine 1000 mg/m2 administered on Days 1 and 8 of the 3-week cycle
DRUG	CNTO888 + Paclitaxel and carboplatin	15 mg/kg CNTO 888 every 3 weeks plus paclitaxel 175 mg/m2 and carboplatin dosed to AUC 6 every 3 weeks
DRUG	CNTO888 + docetaxel	15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks

Timeline

• Start date: 2010-05-01
• Completion: 2011-11-01
• First posted: 2010-09-20
• Last updated: 2012-05-30

Locations

5 sites across 2 countries: United States, Spain