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

Centocor Ortho Biotech

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: CNTO888 + gemcitabine; Drug: CNTO888 + Paclitaxel and carboplatin; Drug: CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection; Drug: CNTO888 + docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01204996

CR016462

CNTO888STM1002 (Other Identifier)

2009-015541-23 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documentation of an advanced solid tumor
• No more than 2 previous anticancer therapies
• good performance status
• adequate bone marrow, liver, and renal function / adequate blood test values
• willing to use birth control measures

Exclusion criteria

• No residual toxicities resulting from previous therapy
• no known allergies, hypersensitivity, or intolerance to antibodies or chemotherapies
• clinically significant bleeding or requiring concurrent therapeutic dose of anticoagulation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 4 patient groups

1

Experimental group

Description:

CNTO888 + docetaxel 15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks

Treatment:

Drug: CNTO888 + docetaxel

2

Experimental group

Description:

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

Treatment:

Drug: CNTO888 + gemcitabine

3

Experimental group

Description:

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

Treatment:

Drug: CNTO888 + Paclitaxel and carboplatin

4

Experimental group

Description:

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

Treatment:

Drug: CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection