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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204996
• Other study ID #: CR016462
• Secondary ID: 2009-015541-23CN
• Status: Completed
• Phase: Phase 1
• First received: September 16, 2010
• Last updated: May 29, 2012
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: May 2012
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetics(rate of movement in the body and then the clearance)		during study as specified in the protocol (interim analysis) and at End of Study (1 year)	No
Secondary	Pharmacodynamics (action of drug on body systems)		during study as specified in the protocol (interim analysis) and at End of Study (1 year)	No