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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: CNTO888 + docetaxel; Drug: CNTO888 + gemcitabine; Drug: CNTO888 + Paclitaxel and carboplatin; Drug: CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection

• Registration Number: NCT01204996
• Lead Sponsor: Centocor, Inc.

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

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-20
• Study Completion: 2011-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-29
• Last Update Posted: 2012-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CNTO888 + docetaxel	CNTO888 + docetaxel 15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks
2	CNTO888 + gemcitabine	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
3	CNTO888 + Paclitaxel and carboplatin	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
4	CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection	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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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)
Pharmacodynamics (action of drug on body systems)	during study as specified in the protocol (interim analysis) and at End of Study (1 year)