Clinical trial NCT01204996: A Study of the Safety and Efficacy of CNTO 888 in Combination With SoC (Standard of Care) Chemotherapy in Patients With Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: monoclonal antibody
solid tumor
chemotherapy
standard of care
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-20
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: During treatment and up to 30 days after last study treatment
Secondary outcomes:
measure: Pharmacokinetics(rate of movement in the body and then the clearance)
timeFrame: during study as specified in the protocol (interim analysis) and at End of Study (1 year)
measure: Pharmacodynamics (action of drug on body systems)
timeFrame: during study as specified in the protocol (interim analysis) and at End of Study (1 year)
Other outcomes:
Locations:
city: Detroit
country: United States
state: Michigan
city: Tacoma
country: United States
state: Washington
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Sanchinarro
country: Spain
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Brana I, Calles A, LoRusso PM, Yee LK, Puchalski TA, Seetharam S, Zhong B, de Boer CJ, Tabernero J, Calvo E. Carlumab, an anti-C-C chemokine ligand 2 monoclonal antibody, in combination with four chemotherapy regimens for the treatment of patients with solid tumors: an open-label, multicenter phase 1b study. Target Oncol. 2015 Mar;10(1):111-23. doi: 10.1007/s11523-014-0320-2. Epub 2014 Jun 15.