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

This study has been completed.
Sponsor:
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT01204996
First received: September 16, 2010
Last updated: May 29, 2012
Last verified: May 2012

September 16, 2010
May 29, 2012
May 2010
Not Provided
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. [ Time Frame: During treatment and up to 30 days after last study treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01204996 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics(rate of movement in the body and then the clearance) [ Time Frame: during study as specified in the protocol (interim analysis) and at End of Study (1 year) ] [ Designated as safety issue: No ]
  • Pharmacodynamics (action of drug on body systems) [ Time Frame: during study as specified in the protocol (interim analysis) and at End of Study (1 year) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
  • 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
  • Experimental: 1
    CNTO888 + docetaxel 15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks
    Intervention: Drug: CNTO888 + docetaxel
  • Experimental: 2
    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
    Intervention: Drug: CNTO888 + gemcitabine
  • Experimental: 3
    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
    Intervention: Drug: CNTO888 + Paclitaxel and carboplatin
  • Experimental: 4
    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
    Intervention: Drug: CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
November 2011
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain
 
NCT01204996
CR016462, 2009-015541-23, CNTO888STM1002
Not Provided
Sr. Director, Clinical Leader, Centocor
Centocor, Inc.
Not Provided
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP